A Phase 2 interventional study of [68Ga]Ga-FAPI-46 in Carcinoma, Intraductal, Noninfiltrating, sponsored by Universität Münster. Recruiting at 2 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-03.
Sponsored by Universität Münster · Phase 2, Interventional, and Diagnostic
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DCIS (ductal carcinoma in situ) is a common pre-stage for breast cancer. The goal of this clinical trial is to learn if FAPI-PET/MRI (an imaging technique with a weakly radioactive drug) helps to diagnose hidden invasive breast cancer in participants with DCIS. The main question it aims to answer is:
How good can FAPI-PET/MRI diagnose hidden invasive breast cancer in DCIS?
Researchers will compare FAPI-PET/MRI results to tissue samples obtained from surgery treatment to see if the FAPI-PET/MRI images show invasive breast cancer certainly.
Participants will
Ductal carcinoma in situ (DCIS) is a common precursor to breast cancer where abnormal cells are present within the milk ducts without breaking through their walls (in situ). If these cancerous cells have already breached the boundaries of the milk ducts, it is referred to as "invasive carcinoma." About half of these precancerous conditions develop further into invasive carcinomas over time. However, since doctors cannot precisely predict this at an individual level, treating DCIS often involves removing the affected tissue to prevent progression towards invasive cancer. Typically, diagnosis relies on performing a biopsy, during which cells from the altered tissue are extracted and examined under a microscope. Unfortunately, determining whether or not an invasive carcinoma has developed is not always possible with certainty with this method; indeed, about one quarter of cases involving existing invasive carcinomas might remain undetected by conventional biopsy procedures.
Consequently, being able to ascertain before surgery if an invasive carcinoma exists or not would be highly beneficial. This study examines a novel method that could potentially enhance the discovery of hidden (also called 'occult') invasive carcinomas. Specifically, it employs positron emission tomography (PET) utilizing a radiopharmaceutical agent known as [68Ga]Ga-FAPI-46. This compound selectively targets and binds to fibroblast activation protein (FAP), abundant on surfaces of tumor-associated fibroblasts. By tagging this structure with a radiotracer, researchers aim to achieve precise visualization and assessment of tumor extent. For the PET examination, a minimal dose of the radiopharmaceutical is administered intravenously while sensitive cameras capture images of particular body sections externally (PET). Additionally, magnetic resonance imaging (MRI) of the breast is conducted concurrently to ensure anatomical orientation, image enhancement (attenuation correction), and additional information acquisition.
The trial visits will be scheduled during the regular treatment process. These will not extend the participant's overall treatment duration significantly, as all measures within the scope of the study typically occur within 30 days, but no more than 51 days. During this period, effective contraception is necessary.
Researchers will then compare the imaging results to the pathology ground truth to evaluate the feasibility of the method.
286 studies on the registry are indexed under Carcinoma, Intraductal, Noninfiltrating; 55 are open to participants now.
This study's planned enrollment of 30 is below the median of 66 across 208 interventional studies indexed under Carcinoma, Intraductal, Noninfiltrating.
Browse Carcinoma, Intraductal, Noninfiltrating studies →Universität Münster is the lead sponsor of 30 studies on the registry; 19 are open to participants now.
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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.
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.
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.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask 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.
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.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
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.
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.
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.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask 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.
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.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
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.
All participants receive the drug \[68Ga\]Ga-FAPI-46 and imaging
Drug: [68Ga]Ga-FAPI-46
Participants receive the weakly radioactive drug \[68Ga\]Ga-FAPI-46 through their vein and lie in an imaging device (PET/MRI) for 30 minutes. After a break of 30 minutes, they will lie in the imaging device for another 15 minutes.
Also known as: [68Ga]FAPI-46
Evaluation of feasibility of detection of occult invasive cancer in diagnosed DCIS of [68Ga]Ga-FAPI-46 breast PET/MRI
Sensitivity based on blinded readers' PET/MRI visual assessment: "Suspicious for occult carcinoma: Yes/No"
Time frame: Within one year after end of trial
Evaluation of feasibility of detection of occult invasive cancer in diagnosed DCIS of [68Ga]Ga-FAPI-46 breast PET/MRI
Specificity based on blinded readers' PET/MRI visual assessment: "Suspicious for occult carcinoma: Yes/No"
Time frame: Within one year after end of trial
Evaluation of feasibility of detection of occult invasive cancer in diagnosed DCIS of [68Ga]Ga-FAPI-46 breast PET/MRI
Optimal threshold based on tumor-to-background ratio of SUVmax (60-75min)
Time frame: Within one year after end of trial
Evaluation of feasibility of detection of occult invasive cancer in diagnosed DCIS of [68Ga]Ga-FAPI-46 breast PET/MRI
Area-under-the-curve of receiver-operating-characteristics curve based on tumor-to-background ratio of SUVmax (60-75min)
Time frame: Within one year after end of trial
Diagnostic Odds Ratio (DOR) to evaluate possible superiority of PET/MRI visual assessment over breast MRI alone
Based on Blinded readers' PET/MRI vs MRI only visual assessment: "Suspicious for occult carcinoma: Yes/No"
Time frame: Within one year after end of trial
Evaluate the added value for diagnostic performance of MRI measures of diffusibility
Sensitivity and specificity of lesion MRI diffusion weighted MRI apparent diffusion coefficient (ADC)
Time frame: Within one year after end of trial
Evaluate the added value for diagnostic performance of MRI measures of perfusion and permeability
Sensitivity and specificity of the DCE-MRI dynamic feature "Maximal Slope"
Time frame: Within one year after end of trial
Evaluate the added value for diagnostic performance of MRI measures of perfusion and permeability
Sensitivity and specificity of the DCE-MRI dynamic feature "Bolus arrival time"
Time frame: Within one year after end of trial
Evaluate the added value for diagnostic performance of MRI measures of perfusion and permeability
Sensitivity and specificity of the DCE-MRI pharmacokinetic modeling parameter: Volume transfer constant (KTrans)
Time frame: Within one year after end of trial
Evaluate the added value for diagnostic performance of MRI measures of perfusion and permeability
Sensitivity and specificity of the DCE-MRI pharmacokinetic modeling parameter: Fractional plasma volume (Vp)
Time frame: Within one year after end of trial
Evaluate the diagnostic performance of the PET parameter SUVmax (60-75min)
Sensitivity and specificity of static PET SUVmax (60-75min)
Time frame: Within one year after end of trial
Evaluate the diagnostic performance of PET pharmacokinetic modeling parameters
Sensitivity and specificity of dynamic PET pharmacokinetic modeling parameter binding potential (BP)
Time frame: Within one year after end of trial
Evaluate impact of PET/MRI on follow-up minimal invasive diagnostic procedures
Number of additional biopsies triggered by PET/MRI visual assessment
Time frame: Within one year after end of trial
Evaluate impact of MRI on follow-up minimal invasive diagnostic procedures
Number of additional biopsies triggered by MRI visual assessment
Time frame: Within one year after end of trial
Evaluate the correspondence of FAP-expression determined by immunohistochemistry and PET
Correlation of immunohistopathology FAP visual staining score with SUVmax (60-75min)
Time frame: Joint analysis of the collected samples after the end of the trial. Samples were collected during regular surgery after the final trial visit.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Adverse events following \[68Ga\]Ga-FAPI-46 application
Time frame: Day of trial medication application and final visit (5-21 days after drug receival)
Started Feb 2026 (actual). Primary completion is estimated for Mar 2028, 25 months after the start.
Of 36 phase 2 interventional studies under Carcinoma, Intraductal, Noninfiltrating, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 117. This study's planned 25 months is below that.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: FAPI-46 GA-68
Carcinoma, Intraductal, Noninfiltrating →
Universität Münster