Multimodal Imaging with FAPI-PET/MRI in Breast Carcinoma-In-Situ for Detection of occult Invasive cancer (MI-CISDIR)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Universitaet Muenster

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

20 Feb 2026 → ongoing

Decision date (initial)

2024-04-25

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

University of Münster

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Diagnosis

Evaluation of feasibility of detection of occult invasive cancer in diagnosed DCIS of [68Ga]Ga-FAPI-46 breast PET/MRI

Secondary objectives 13

1. Evaluation of feasibility of detection of occult invasive cancer in diagnosed DCIS of [68Ga]Ga-FAPI-46 breast PET/MRI
2. Evaluating possible superiority of PET/MRI visual assessment over breast MRI alone
3. Evaluate the added value for diagnostic performance of MRI measures of diffusibility
4. Evaluate the added value for diagnostic performance of MRI measures of perfusion and permeability
5. Evaluate the added value for diagnostic performance of MRI measures of perfusion and permeability
6. Evaluate the added value for diagnostic performance of MRI measures of perfusion and permeability
7. Evaluate the added value for diagnostic performance of MRI measures of perfusion and permeability
8. Evaluate the diagnostic performance of the PET parameter SUVmax (60-75min)
9. Evaluate the diagnostic performance of PET pharmacokinetic modeling parameters
10. Evaluate impact of PET/MRI on follow-up minimal invasive diagnostic procedures
11. Evaluate impact of MRI on follow-up minimal invasive diagnostic procedures
12. Evaluate the correspondence of FAP-expression determined by immunohistochemistry and PET
13. Evaluate the safety of [68Ga]Ga-FAPI-46

Conditions and MedDRA coding

Ductal carcinoma in situ

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Newly diagnosed DCIS with extent in mammography, MRI or ultrasound suspected to range > 4 cm
2. Planned DCIS resection (breast conserving or mastectomy) as per guideline recommendation
3. Age ≥ 18 years
4. Written informed consent
5. For women of childbearing potential: confirmed menstrual period (if applicable) and a negative highly sensitive urine or serum pregnancy test
6. Women of childbearing potential (WOCBP) and fertile 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.

Exclusion criteria 8

1. Contraindications for MRI (specific metallic implants, severe claustrophobia, history of anaphylaxis following MRI contrast agent application)
2. GFR < 30 mL/(min∙1.73 m^2)
3. Current pregnancy or pregnancy within 8 weeks before begin of study participation
4. Current nursing or nursing within 8 weeks before begin of study participation
5. Inability to understand the nature, risks, and benefits of the study
6. History of diagnosis of ipsilateral invasive breast cancer
7. Concurrent diagnosis of contralateral invasive cancer, if not curatively treated by surgery > 1 year ago
8. Known hypersensitivity to the active substance or to any of the excipients of the IMP

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Sensitivity based on blinded readers‘ PET/MRI visual assessment score
2. Specificity based on blinded readers‘ PET/MRI visual assessment score

Secondary endpoints 13

1. Optimal threshold and area-under-the-curve of receiver-operating- characteristics curve based on tumor-to-background ratio of SUVmax (60-75min)
2. Diagnostic Odds Ratio (DOR) based on Blinded readers’ PET/MRI vs MRI only visual assessment score
3. Sensitivity and specificity of lesion MRI diffusion weighted MRI apparent diffusion coefficient (ADC)
4. Sensitivity and specificity of the DCE-MRI dynamic feature “Maximal Slope”
5. Sensitivity and specificity of the DCE-MRI dynamic feature “Bolus arrival time”
6. Sensitivity and specificity of the DCE-MRI pharmacokinetic modeling parameter: Volume transfer constant (KTrans)
7. Sensitivity and specificity of the DCE-MRI pharmacokinetic modeling parameter: Fractional plasma volume (Vp)
8. Sensitivity and specificity of static PET SUVmax (60-75min)
9. Sensitivity and specificity of dynamic PET pharmacokinetic modeling parameter binding potential (BP)
10. Number of additional biopsies triggered by PET/MRI visual assessment
11. Number of additional biopsies triggered by MRI visual assessment
12. Correlation of immunohistopathology FAP visual staining Score with SUVmax (60-75min)
13. Adverse events following [68Ga]Ga-FAPI-46 application

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Universitaet Muenster

Sponsor organisation

Universitaet Muenster

Address

Schlossplatz 2, Schlossbezirk Schlossbezirk

City

Muenster

Postcode

48149

Country

Germany

Scientific contact point

Organisation

Universitaet Muenster

Contact name

Trial coordinator

Public contact point

Organisation

Universitaet Muenster

Contact name

Trial coordinator

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 1 file

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications