Carcinoma, Intraductal, NoninfiltratingPhase 2MI-CISDIRNCT06540872
Multimodal Imaging With FAPI-PET/MRI in Breast Carcinoma-In-Situ for Detection of Occult Invasive Cancer
A Phase 2 study testing [68Ga]Ga-FAPI-46 in people with Carcinoma, Intraductal, Noninfiltrating, run by Universität Münster at 2 sites in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Intraductal, Noninfiltrating
- What is being tested?
- [68Ga]Ga-FAPI-46
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesGermany
- Study dates
- 20 Feb 2026to Mar 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed DCIS with extent in mammography, MRI or ultrasound suspected to range > 4 cm
- Planned DCIS resection (breast conserving or mastectomy) as per guideline recommendation
- Written informed consent
- For women of child bearing potential: confirmed menstrual period (if applicable) and a negative highly sensitive urine or serum pregnancy test
- Women of childbearing potential (WOCBP) and male patients with partners of childbearing/reproductive potential must agree to use highly effective contraception (Pearl index < 1) when sexually active. This applies for the time period between signing of the informed consent form up to the final trial visit.
Who cannot join
- Contraindications for MRI (specific metallic implants, severe claustrophobia, history of anaphylaxis following MRI contrast agent application)
- GFR < 30 mL/(min∙1.73 m²)
- Current pregnancy or within last 8 weeks before begin of study participation
- Current nursing or within last 8 weeks before begin of study participation
- Inability to understand the nature, risks, and benefits of the study
- History of diagnosis of ipsilateral invasive breast cancer
- Concurrent diagnosis of contralateral invasive cancer, if not curatively treated by surgery > 1 year ago
- Known hypersensitivity to the active substance or to any of the excipients of the Investigational Medicinal Product
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany2 sites, 2 recruiting
- Not yet recruiting
Department of Nuclear Medicine, University Hospital Essen
Essen, North Rhine-Westphalia, 45147
Ken Herrmann, Prof., +49201723 ext. 2073, Sekretariat.Nuklearmedizin@uk-essen.de
Kim Pabst, Dr. med., +49201723 ext. 2073, Sekretariat.Nuklearmedizin@uk-essen.de
- Recruiting
Department of Nuclear Medicine, University Hospital Münster
Münster, North Rhine-Westphalia, 48149
Philipp Backhaus, Dr. med., +4925183 ext. 47362, nuklearmedizin@ukmuenster.de
Michael Schäfers, Prof., +4925183 ext. 47362, nuklearmedizin@ukmuenster.de
About this study
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
- receive the radioactive drug and lie in an imaging device for 45 minutes including a break
- visit the clinic once again for a checkup and test
Read the detailed description
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.
- Conditions
- Carcinoma, Intraductal, Noninfiltrating
- Being tested
- [68Ga]Ga-FAPI-46
- Keywords
- breast cancer, PET/MRI, DCIS, ductal carcinoma in situ, FAPI
- Medical subject headings
- Carcinoma, Intraductal, Noninfiltrating, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[68Ga]Ga-FAPI-46Drug
Also called [68Ga]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.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | All participants receive the drug [68Ga]Ga-FAPI-46 and imaging Receives: Drug: [68Ga]Ga-FAPI-46 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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"
Measured: 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"
Measured: Within one year after end of trial
Secondary outcomes (14)
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)
Measured: 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)
Measured: 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"
Measured: 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)
Measured: 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"
Measured: 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"
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: Day of trial medication application and final visit (5-21 days after drug receival)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start20 Feb 2026
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Intraductal, NoninfiltratingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universität Münster
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philipp Backhaus, Dr. med., Principal investigator, Department of Nuclear Medicine, University Hospital Münster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06540872
- Sponsor's protocol ID
- WWU22_0012
- Other IDs
- 2023-509860-47-00, 2023
- Acronym
- MI-CISDIR
- Status last verified
- Feb 2026
- First submitted
- 11 Jun 2024
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Imaging With FAPI-PET/MRI in Breast Carcinoma-In-Situ for Detection of Occult Invasive Cancer
- ClinicalTrials.gov ID
- NCT06540872
- Acronym / sponsor ID
- MI-CISDIR / WWU22_0012
- Conditions
- Carcinoma, Intraductal, Noninfiltrating
- Keywords
- breast cancer, PET/MRI, DCIS, ductal carcinoma in situ, FAPI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universität MünsterUniversity, hospital or other
- Study start
- 20 Feb 2026 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 6 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- receive the radioactive drug and lie in an imaging device for 45 minutes including a break
- visit the clinic once again for a checkup and test
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: [68Ga]Ga-FAPI-46All participants receive the drug [68Ga]Ga-FAPI-46 and imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Newly diagnosed DCIS with extent in mammography, MRI or ultrasound suspected to range > 4 cm
- Planned DCIS resection (breast conserving or mastectomy) as per guideline recommendation
- Written informed consent
- For women of child bearing potential: confirmed menstrual period (if applicable) and a negative highly sensitive urine or serum pregnancy test
- Women of childbearing potential (WOCBP) and male patients with partners of childbearing/reproductive potential must agree to use highly effective contraception (Pearl index < 1) when sexually active. This applies for the time period between signing of the informed consent form up to the final trial visit.
Key exclusion criteria (8 listed)
- Contraindications for MRI (specific metallic implants, severe claustrophobia, history of anaphylaxis following MRI contrast agent application)
- GFR < 30 mL/(min∙1.73 m²)
- Current pregnancy or within last 8 weeks before begin of study participation
- Current nursing or within last 8 weeks before begin of study participation
- Inability to understand the nature, risks, and benefits of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [68Ga]Ga-FAPI-46Also: [68Ga]FAPI-46Participants 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. | Drug | Single Arm |
Primary outcome
Evaluation of feasibility of detection of occult invasive cancer in diagnosed DCIS of [68Ga]Ga-FAPI-46 breast PET/MRI
Time frame: Within one year after end of trial
Sensitivity based on blinded readers' PET/MRI visual assessment: "Suspicious for occult carcinoma: Yes/No"
Evaluation of feasibility of detection of occult invasive cancer in diagnosed DCIS of [68Ga]Ga-FAPI-46 breast PET/MRI
Time frame: Within one year after end of trial
Specificity based on blinded readers' PET/MRI visual assessment: "Suspicious for occult carcinoma: Yes/No"
14 secondary outcomes
Evaluation of feasibility of detection of occult invasive cancer in diagnosed DCIS of [68Ga]Ga-FAPI-46 breast PET/MRI
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
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
Time frame: Within one year after end of trial
Evaluate the added value for diagnostic performance of MRI measures of diffusibility
Time frame: Within one year after end of trial
Evaluate the added value for diagnostic performance of MRI measures of perfusion and permeability
Time frame: Within one year after end of trial
Evaluate the added value for diagnostic performance of MRI measures of perfusion and permeability
Time frame: Within one year after end of trial
Evaluate the added value for diagnostic performance of MRI measures of perfusion and permeability
Time frame: Within one year after end of trial
Evaluate the added value for diagnostic performance of MRI measures of perfusion and permeability
Time frame: Within one year after end of trial
Evaluate the diagnostic performance of the PET parameter SUVmax (60-75min)
Time frame: Within one year after end of trial
Evaluate the diagnostic performance of PET pharmacokinetic modeling parameters
Time frame: Within one year after end of trial
Evaluate impact of PET/MRI on follow-up minimal invasive diagnostic procedures
Time frame: Within one year after end of trial
Evaluate impact of MRI on follow-up minimal invasive diagnostic procedures
Time frame: Within one year after end of trial
Evaluate the correspondence of FAP-expression determined by immunohistochemistry and PET
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]
Time frame: Day of trial medication application and final visit (5-21 days after drug receival)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
Related trials for Carcinoma, Intraductal, Noninfiltrating
RecruitingObservational study
Preoperative vs. Pathologic Size in Breast Cancer: A Prospective Study
Mastectomy, Breast Neoplasm Malignant Primary
Not yet recruiting
Agentic AI App and Home Bioimpedance Monitoring for Endocrine Therapy Adherence and Lymphedema in Breast Cancer Survivors
Breast Neoplasm Malignant Primary, Lymphedema Arm
Not yet recruiting
Addressing Financial Hardship in AYA Cancer Survivors Through the Use of the New LIFT UP Intervention
Breast Ductal Carcinoma In Situ, Hematopoietic and Lymphatic System Neoplasm
RecruitingPhase 2
DCIS: RECAST Trial Ductal Carcinoma In Situ: Re-Evaluating Conditions for Active Surveillance Suitability as Treatment
Ductal Carcinoma in Situ
Active, not recruitingPhase 3
Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients With Invasive RxPONDER Breast Cancer
Breast Ductal Carcinoma In Situ, Invasive Breast Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Philipp Backhaus, Dr. med. principal investigator
Department of Nuclear Medicine, University Hospital Münster
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing [68Ga]Ga-FAPI-46 in people with Carcinoma, Intraductal, Noninfiltrating, run by Universität Münster at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Philipp Backhaus, Dr. med. (+4925183 ext. 47362, nuklearmedizin@ukmuenster.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of feasibility of detection of occult invasive cancer in diagnosed DCIS of [68Ga]Ga-FAPI-46 breast PET/MRI (time frame: Within one year after end of trial). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.