A Phase 1 interventional study of 68Ga-Galmydar and PET/MRI in Lymphoma Cancer, Breast Cancer and Cancer of the Breast, sponsored by Washington University School of Medicine. Not yet recruiting at 1 site in United States. Open to participants aged 21 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Washington University School of Medicine · Phase 1, Interventional, and Diagnostic
This study is a single center, phase 1 clinical imaging study designed to assess the role of 68Ga-Galmydar Positron Emission Tomography (PET) imaging for detection of cardiotoxicity in human subjects with breast cancer or lymphoma undergoing treatment with anthracycline for cancer therapy.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 36 is below the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Washington University School of Medicine is the lead sponsor of 1,803 studies on the registry; 271 are open to participants now.
Of its 329 completed or terminated interventional studies of FDA-regulated products, 216 (66%) have results posted.
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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:
Any condition that in the opinion of the Principal Investigator or designee could increase risk to the participant, limit the participant's ability to tolerate the research procedures or interfere with collection of the data such as:
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.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
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.
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).
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
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.
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.
Lymphoma patients: baseline prior to the start of chemotherapy treatment, after the patient has had at least 250 mg/m\^2 of anthracycline (after the 5th cycle \& before the 6th cycle of anthracycline in Non-Hodgkin lymphoma or after the 5th cycle (10 treatments) in Hodgkin lymphoma, 1-3 weeks after the 5th cycle of anthracycline), and 12-months (+/- 1 month) post-treatment Breast patients: baseline prior to the start of all chemotherapy treatments, baseline after Paclitaxel and prior to the start of AC (Adriamycin \& Cyclophosphamide) for patients treated with the Keynote-522 regimen, 1-2 weeks after the last dose (4 cycles) of AC, and 12-months (+/- 1 month) post-treatment Echocardiography will be performed at all PET imaging sessions \& at 6- and 9-months post-chemotherapy A subset of 3 breast \& 3 lymphoma patients will undergo 18F-FDG PET/MRI. Patients undergoing 18F-FDG PET/MRI will stay overnight \& will be imaged with 18F-FDG in the morning on day 2 under fasting conditions
Drug: 68Ga-Galmydar · Device: PET/MRI · Drug: 18F-FDG
68Ga-Galmydar is a positron-emitting radioisotope used prior to PET/MRI imaging. Prior to imaging, patients will receive one single intravenous administration of 2.5 mCi ± 20% (2.0-3.0 mCi) of 68Ga-Galmydar followed by a 10 mL normal saline flush on Imaging Day -1.
Also known as: Ga-Galmydar
Patients will undergo PET/MRI according to standard of care imaging.
Also known as: Positron Emission Tomography/Magnetic Resonance Imaging, PET/MR, PET-MRI
18F-FDG is administered by an intravenous injection of 10 mCi ± 20% (8-12 mCi) followed by a 10 mL normal saline flush.
Also known as: F-FDG, FDG
Changes in 68Ga-Galmydar Standardized Uptake Value (SUV) in patients with and without cardiotoxicity
The ability of 68Ga-Galmydar PET/MRI to detect chemotherapy-induced cardiotoxicity will be determined by measuring changes in PET signal (SUV) over time in patients with and without cardiotoxicity. Classification of whether or not a patient develops cardiotoxicity will be determined by evaluation of the left ventricular ejection fraction (LVEF) on echocardiography. Cardiac SUVmean values between pre- and post-chemotherapy will be obtained from PET scans. SUV quantifies the percent of radiotracer that accumulates in a region compared with if the tracer was distributed throughout the body. Mixed effects regression (MER) will be used to examine decreased uptake in those with cardiotoxicity compared to those without toxicity. The regression coefficient for time-by-group interaction will describe the different time trend of SUV uptake over time between two groups.
Time frame: From baseline imaging through 12 months post treatment imaging (total estimated time 57-58 weeks)
Correlation between 68Ga-Galmydar PET signal and the 18F-FDG PET signal
The relationship between 68Ga-Galmydar PET signal to 18F-FDG PET signal will be indicated using a Pearson or Spearman coefficient, whichever is appropriate. Spearman's correlation coefficient evaluates the association and the association's direction between two ranked continuous variables. Spearman's correlation coefficient ranges from -1 to 1, with a negative number indicating a negative relationship between variables and a positive number indicating a positive relationship between variables. Values closer to zero indicate a weak relationship. Pearson's correlation coefficient is a measure that evaluates the association between two continuous variables with the assumption that the variables have a linear relationship. Pearson's correlation coefficient ranges from -1 to 1, with a negative number indicating a negative relationship between variables and a positive number indicating a positive relationship between variables. Values closer to zero indicate a weak relationship.
Time frame: From baseline imaging through 12 months post treatment imaging (total estimated time 57-58 weeks)
Correlation of PET signal and Left Ventricular Ejection Fraction (LVEF) from echocardiography
Echocardiography will be conducted prior to starting chemotherapy, at each of the PET/MR visits, and at 6 and 9-months post-chemotherapy for left ventricular function assessment. LVEF is the percentage of blood in the heart's left ventricle that ejects with each contraction. LVEF is calculated by the following equation: LVEF = (End Diastolic Volume (EDV) - End Systolic Volume (ESV)) / EDV × 100 The relationship between LVEF changes and LV-SUV will be assessed similarly with a Pearson correlation.
Time frame: From baseline imaging through 12 months post treatment imaging (total estimated time 57-58 weeks)
Correlation of PET signal and Left Ventricular Ejection Fraction (LVEF) from MR
MR will be performed with each PET imaging scan. LVEF is the percentage of blood in the heart's left ventricle that ejects with each contraction. LVEF is calculated by the following equation: LVEF = (End Diastolic Volume (EDV) - End Systolic Volume (ESV)) / EDV × 100 The relationship between LVEF changes and LV-SUV will be assessed similarly with a Pearson correlation.
Time frame: From baseline imaging through 12 months post treatment imaging (total estimated time 57-58 weeks)
Sensitivity of 68Ga-Galmydar
Sensitivity is calculated as the proportion of true positives divided by the sum of true positives and false negatives. Rate of sensitivity and corresponding 95% confidence interval will be reported.
Time frame: From baseline imaging through 12 months post treatment imaging (total estimated time 57-58 weeks)
Specificity of 68Ga-Galmydar
Specificity is calculated as the proportion of true negatives divided by the sum of true negatives and false positives. Rate of specificity and corresponding 95% confidence interval will be reported.
Time frame: From baseline imaging through 12 months post treatment imaging (total estimated time 57-58 weeks)
Comparison of segmental 68Ga-Galmydar PET SUV to native T1 values from MR
The myocardial wall segment analysis will be performed using the American Heart Association (AHA) model.
Time frame: From baseline imaging through 12 months post treatment imaging (total estimated time 57-58 weeks)
Comparison of global 68Ga-Galmydar PET SUV to native T1 values from MR
Time frame: From baseline imaging through 12 months post treatment imaging (total estimated time 57-58 weeks)
Comparison of segmental 68Ga-Galmydar PET SUV to native T2 values from MR
The myocardial wall segment analysis will be performed using the American Heart Association (AHA) model.
Time frame: From baseline imaging through 12 months post treatment imaging (total estimated time 57-58 weeks)
Comparison of global 68Ga-Galmydar PET SUV to native T2 values from MR
Time frame: From baseline imaging through 12 months post treatment imaging (total estimated time 57-58 weeks)
Comparison of global 68Ga-Galmydar PET SUV to global longitudinal strain from MR
Time frame: From baseline imaging through 12 months post treatment imaging (total estimated time 57-58 weeks)
Comparison of global 68Ga-Galmydar PET SUV to global circumferential strain from MR
Time frame: From baseline imaging through 12 months post treatment imaging (total estimated time 57-58 weeks)
Plan to share: Yes — The raw data from the project (MRI, PET, CMP, CBC, Lipid panel, demographic, clinical data, including demographic, along with details on the dose administered) will be preserved and shared. All data will be de-identified prior to receipt by the repository. PET imaging and clinical data will be deposited into Open-Access Series of Imaging Studies (OASIS). Metadata and data dictionary will be shared and made accessible.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: The research community will have access to the data 12 months after the award begins, or once it is published or the grant award has been completed - whichever comes first. There is no time limit for expiration of data.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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