A Phase 2/3 interventional study of Mangaciclanol, also known as GEH200486 Injection, 0.5 mmol/mL and MRI Scan in Known or Highly Suspected Central Nervous System (CNS) Lesion and Known or Highly Suspected Body (Excluding CNS) Lesion, sponsored by GE Healthcare. Recruiting at 7 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-29.
Sponsored by GE Healthcare · Phase 2/3, Interventional, and Diagnostic
This is an operationally combined Phase 2/3 study, which will be conducted and evaluated in 2 distinct parts:
The investigational medicinal products (IMPs) used during the trial are mangaciclanol and gadobutrol (comparator IMP).
Primary and key secondary efficacy analyses will be based on independent central blinded image evaluation (BIE), and Phase 2 data will be analyzed prior to commencement of Phase 3.
GE Healthcare is the lead sponsor of 176 studies on the registry; 21 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 16 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An initial dose of 0.1 mmol/kg mangaciclanol will be compared to the standard dose of gadobutrol (0.1 mmol/kg) in Cohort 1, in approximately 60 participants. A second cohort (Cohort 2) may be initiated based on the outcome of the analysis of Cohort 1. This cohort will include approximately 60 participants (higher or lower dose), or 30 participants (same dose), depending on the dose of mangaciclanol selected for further evaluation.
Drug: Mangaciclanol, also known as GEH200486 Injection, 0.5 mmol/mL · Diagnostic Test: MRI Scan · Drug: Gadobutrol
Participants with known or highly suspected lesions of CNS or body, randomized to receive treatment sequence mangaciclanol (V2) followed by gadobutrol (V4)
Drug: Mangaciclanol, also known as GEH200486 Injection, 0.5 mmol/mL · Diagnostic Test: MRI Scan · Drug: Gadobutrol
Participants with known or highly suspected lesions of CNS or body, randomized to receive treatment sequence gadobutrol (V2) followed by mangaciclanol (V4)
Drug: Mangaciclanol, also known as GEH200486 Injection, 0.5 mmol/mL · Diagnostic Test: MRI Scan · Drug: Gadobutrol
Single intravenous (IV) administration of Mangaciclanol (GEH200486 Injection, 0.5 mmol/mL) followed by a 20mL saline flush
MRI Scan starting prior to IMP administration and continuing for up to 60 minutes post IMP administration
Single intravenous (IV) administration of Gadobutrol (0.1 mmol/kg) followed by a 20mL saline flush
Phase 2 Primary Endpoint - Overall diagnostic preference
Overall diagnostic preference based on global matched pairs reads according to a 3-point scale that is derived from a 5-point scale (1 = greatly prefer mangaciclanol/prefer mangaciclanol, 0 = no preference, -1 = prefer gadobutrol/greatly prefer gadobutrol), as evaluated by 3 blinded independent readers.
Time frame: 4-47 days
Phase 3 Primary Endpoint - Lesion visualization criteria
Lesion visualization criteria (lesion border delineation, internal morphology and degree of lesion contrast enhancement) for paired (unenhanced plus mangaciclanol-enhanced) MRIs compared to unenhanced MRI based on the primary reads on a 4-point scale (1 = poor / none; 2 = moderate; 3 = good; 4 = excellent) for up to 3 of the most representative lesions.
Time frame: 4-74 days
Phase 2 Secondary Endpoint - Lesion visualization criteria
Lesion visualization criteria (lesion border delineation, internal morphology, and degree of lesion contrast enhancement) on a 4-point scale (1 = poor / none; 2 = moderate; 3 = good; 4 = excellent) for up to 3 of the most representative lesions based on the primary reads.
Time frame: 4-47 days
Phase 2 Secondary Endpoint - Number of lesions
Number of lesions based on global matched pairs reads and primary reads, and size and location of up to 3 of the most representative lesions based on the primary reads.
Time frame: 4-47 days
Phase 2 Secondary Endpoint - Technical adequacy of images for diagnosis
Technical adequacy of images for diagnosis according to categorical assessment of image quality based on the primary reads.
Time frame: 4-47 days
Phase 2 Secondary Endpoint - Contrast enhancement percentage (CE%)
Quantitative measurements of percentage of contrast enhancement (CE%) between unenhanced and contrast-enhanced images, will be determined per participant as the average for up to 3 of the most representative lesions (i.e., the same lesions identified for assessment of lesion visualization scores) based on evaluation of paired (unenhanced and contrast-enhanced) images
Time frame: 4-47 days
Phase 2 Secondary Endpoint - contrast-to-noise ratio (CNR)
Quantitative measurements of contrast-to-noise ratio (CNR) and change in CNR (ΔCNR) between unenhanced and contrast-enhanced images, will be determined per participant as the average for up to 3 of the most representative lesions (i.e., the same lesions identified for assessment of lesion visualization scores) based on evaluation of paired (unenhanced and contrast-enhanced) images.
Time frame: 4-47 days
Phase 2 Secondary Endpoint - signal-to-noise ratio (SNR)
Quantitative measurements of signal-to-noise ratio (SNR) will be determined per participant as the average for up to 3 of the most representative lesions (i.e., the same lesions identified for assessment of lesion visualization scores) based on evaluation of paired (unenhanced and contrast-enhanced) images.
Time frame: 4-47 days
Phase 2 Secondary Endpoint - Intra-reader reproducibility regarding overall diagnostic preference (primary endpoint).
Intra-reader reproducibility (from 10% re-read) will be analyzed for overall diagnostic preference according to a 3-point scale (as nominal response) and a 5-point scale (as ordinal response with linear relationship).
Time frame: 4-47 days
Phase 2 Secondary Endpoint - Inter-reader agreement regarding overall diagnostic preference (primary endpoint).
Inter-reader agreement will be analyzed for overall diagnostic preference according to a 3-point scale (as nominal response) and a 5-point scale (as ordinal response with linear relationship).
Time frame: 4-47 days
Phase 2 Secondary Endpoint - Incidence of TEAEs
Incidence of treatment-emergent adverse events (TEAEs).
Time frame: 4-47 days
Number and percentage of participants with changes from baseline in serum biochemistry laboratory test results
Absolute value and change from pre-MRI in serum biochemistry laboratory test results
Time frame: 4-47 days
Phase 2 Secondary Endpoint - Number and percentage of participants with changes from baseline in hematology laboratory test results
Absolute value and change from pre-MRI in hematology laboratory test results.
Time frame: 4-47 days
Phase 2 Secondary Endpoint - Number and percentage of participants with changes from baseline in urinalysis test results
Absolute value and change from pre-MRI in urinalysis test results.
Time frame: 4-47 days
Phase 2 Secondary Endpoint - Number and percentage of participants with changes from baseline in systolic and diastolic blood pressure
Absolute value and change from pre-MRI in systolic and diastolic blood pressure in millimeters of mercury.
Time frame: 4-47 days
Phase 2 Secondary Endpoint - Number and percentage of participants with changes from baseline in respiratory rate
Absolute value and change from pre-MRI in respiratory rate (breaths per minute).
Time frame: 4-47 days
Phase 2 Secondary Endpoint - Number and percentage of participants with changes from baseline in heart rate
Absolute value and change from pre-MRI in heart rate (beats per minute).
Time frame: 4-47 days
Phase 2 Secondary Endpoint - Number and percentage of participants with changes from baseline in temperature
Absolute value and change from pre-MRI in temperature (degrees Celsius).
Time frame: 4-47 days
Phase 2 Secondary Endpoint - Number and percentage of participants with changes from baseline in electrocardiogram examinations
Absolute value and change from pre-MRI in electrocardiogram examinations (PR, QRS, and QTcF).
Time frame: 4-47 days
Phase 2 Secondary Endpoint - Number and percentage of participants with changes from baseline in physical examination findings
Absolute value and change from pre-MRI in physical examination findings.
Time frame: 4-47 days
Phase 2 Secondary Endpoint - Incidence of abnormal safety parameters
Incidence of abnormal vital signs, 12-lead ECG, physical examination, clinical laboratory parameters, and urinalysis results.
Time frame: 4-47 days
Phase 3 Secondary Endpoints - Lesion Visualization
Lesion visualization criteria (lesion border delineation, internal morphology, and degree of contrast enhancement) for paired (unenhanced and contrast-enhanced) MRIs based on primary reads of images acquired with mangaciclanol as compared to gadobutrol, according to a 4-point scale for up to 3 of the most representative lesions.
Time frame: 4-74 days
Phase 3 Secondary Endpoints - Overall diagnostic preference based on global matched pairs reads
Overall diagnostic preference based on global matched pairs reads according to a 3-point scale that is derived from a 5-point scale (1 = greatly prefer/prefer mangaciclanol; 0 = no preference; ˗1 = greatly prefer/prefer gadobutrol), as evaluated by 3 blinded independent readers.
Time frame: 4-74 days
Phase 3 Secondary Endpoints - Number of lesions
Number of lesions based on global matched pairs reads, on-site investigator reads and primary reads, and size and location of up to 3 of the most representative lesions based on primary reads and on-site investigator reads.
Time frame: 4-74 days
Phase 3 Secondary Endpoints - Technical adequacy of images for diagnosis
Technical adequacy of images for diagnosis according to a categorical assessment of image quality based on the primary reads and the on-site investigator reads will be described only in terms of number and percentage of participants.
Time frame: 4-74 days
Phase 3 Secondary Endpoints - Patient diagnosis and diagnostic confidence
Patient diagnosis and diagnostic confidence according to a 5-point scale (nil, poor, moderate, high, excellent) based on primary reads and on-site investigator reads.
Time frame: 4-74 days
Phase 3 Secondary Endpoints - Contrast enhancement percentage (CE%)
Quantitative measurements of percentage of contrast enhancement (CE%) between unenhanced and contrast-enhanced images, will be determined per participant as the average for up to 3 of the most representative lesions (i.e., the same lesions identified for assessment of lesion visualization scores) based on evaluation of paired (unenhanced and contrast-enhanced) images.
Time frame: 4-74 days
Phase 3 Secondary Endpoints - contrast-to-noise ratio (CNR)
Quantitative measurements of contrast-to-noise ratio (CNR) and change in CNR (ΔCNR) between unenhanced and contrast-enhanced images, will be determined per participant as the average for up to 3 of the most representative lesions (i.e., the same lesions identified for assessment of lesion visualization scores) based on evaluation of paired (unenhanced and contrast-enhanced) images.
Time frame: 4-74 days
Phase 3 Secondary Endpoints - signal-to-noise ratio (SNR)
Quantitative measurements of signal-to-noise ratio (SNR) will be determined per participant as the average for up to 3 of the most representative lesions (i.e., the same lesions identified for assessment of lesion visualization scores) based on evaluation of paired (unenhanced and contrast-enhanced) images.
Time frame: 4-74 days
Phase 3 Secondary Endpoints - Lesion visualization criteria
Lesion visualization criteria for unenhanced and paired (unenhanced and contrast-enhanced) MRIs based on the on-site investigator (radiologists) reads for up to 3 of the most representative lesions.
Time frame: 4-74 days
Phase 3 Secondary Endpoints - Per-lesion sensitivity
Per-lesion sensitivity of mangaciclanol-enhanced and gadobutrol-enhanced MRI for detection of malignancy, based on histopathological reference standard
Time frame: 4-74 days
Phase 3 Secondary Endpoints - Per-lesion specificity
Per-lesion specificity of mangaciclanol-enhanced and gadobutrol-enhanced MRI for detection of malignancy, based on histopathological reference standard
Time frame: 4-74 days
Phase 3 Secondary Endpoints - The impact on patient treatment plan
The impact on patient treatment plan (yes/no; including resection, biopsy, chemotherapy, radiotherapy, other specified treatment) as assessed by the on-site investigator for each contrast agent.
Time frame: 4-74 days
Phase 3 Secondary Endpoints - Intra-reader reproducibility regarding lesion visualization criteria (primary endpoint)
Intra-reader reproducibility will be evaluated for lesion visualization criteria (lesion border delineation, internal morphology and degree of contrast enhancement) for each treatment using a Bland-Altman plot for absolute agreement on a subset of participants with re-reads (10%). Descriptive statistics will be provided for the first vs. second measurement, as well as for the minimum vs. maximum values. Additionally, descriptive statistics will be presented for the absolute value of the paired differences between the 2 measurements.
Time frame: 4-74 days
Phase 3 Secondary Endpoints - Inter-reader agreement regarding lesion visualization criteria (primary endpoint)
Inter-reader agreement will be analyzed using both a 2-way random effect model for consistency and absolute agreement to calculate intraclass correlation coefficients.
Time frame: 4-74 days
Phase 3 Secondary Endpoints - Incidence of participants with at least 1 new lesion detected
Incidence of participants with at least 1 new lesion detected on paired MRI compared to unenhanced MRI based on global matched pairs reads.
Time frame: 4-74 days
Phase 3 Secondary Endpoints - Incidence of Treatment Emergent Adverse Events (TEAEs)
Incidence of TEAEs.
Time frame: 4-74 days
Phase 3 Secondary Endpoints - Number and percentage of participants with changes from baseline in serum biochemistry laboratory test results
Absolute value and change from pre-MRI serum biochemistry laboratory test results.
Time frame: 4-74 days
Phase 3 Secondary Endpoint - Number and percentage of participants with changes from baseline in hematology laboratory test results
Absolute value and change from pre-MRI in hematology laboratory test results.
Time frame: 4-74 days
Phase 3 Secondary Endpoint - Number and percentage of participants with changes from baseline in urinalysis test results
Absolute value and change from pre-MRI in urinalysis test results.
Time frame: 4-74 days
Phase 3 Secondary Endpoint - Number and percentage of participants with changes from baseline in systolic and diastolic blood pressure
Absolute value and change from pre-MRI in systolic and diastolic blood pressure in millimeters of mercury.
Time frame: 4-74 days
Phase 3 Secondary Endpoint - Number and percentage of participants with changes from baseline in respiratory rate
Absolute value and change from pre-MRI in respiratory rate (breaths per minute).
Time frame: 4-74 days
Phase 3 Secondary Endpoint - Number and percentage of participants with changes from baseline in heart rate
Absolute value and change from pre-MRI in heart rate (beats per minute).
Time frame: 4-74 days
Phase 3 Secondary Endpoint - Number and percentage of participants with changes from baseline in temperature
Absolute value and change from pre-MRI in temperature (degrees Celsius).
Time frame: 4-74 days
Phase 3 Secondary Endpoint - Number and percentage of participants with changes from baseline in physical examination findings
Absolute value and change from pre-MRI in physical examination findings.
Time frame: 4-74 days
Phase 3 Secondary Endpoints - Incidence of abnormal safety parameters
Incidence of abnormal vital signs, physical examination, clinical laboratory parameters, and urinalysis results.
Time frame: 4-74 days
Plan to share: Undecided
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Started Apr 2026 (actual). Primary completion is estimated for Nov 2027, 19 months after the start.
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