Multimodal Imaging With FAPI-PET/MRI in Breast Carcinoma-In-Situ for Detection of Occult Invasive Cancer

NCT06540872 | Not Yet Recruiting Phase 2

• 2 other identifiers: WWU22_00122023-509860-47-00
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief 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. 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

Conditions

Carcinoma, Intraductal, Noninfiltrating

Keywords

breast cancer; PET/MRI; DCIS; ductal carcinoma in situ; FAPI

Outcome Measures

Primary Outcomes (2)

• 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"

  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"

  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

  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

  Within one year after end of trial

• Diagnostic Odds Ratio (DOR) to evaluate possible superiority of PET/MRI visual assessment over breast MRI alone

  Within one year after end of trial

• Evaluate the added value for diagnostic performance of MRI measures of diffusibility

  Within one year after end of trial

• Evaluate the added value for diagnostic performance of MRI measures of perfusion and permeability

  Within one year after end of trial

Study Arms (1)

Single Arm

EXPERIMENTAL

All participants receive the drug \[68Ga\]Ga-FAPI-46 and imaging

Drug: [68Ga]Ga-FAPI-46

Interventions

[68Ga]Ga-FAPI-46 DRUG

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

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universität Münster: lead

Study Sites (2)

Department of Nuclear Medicine, University Hospital Essen

Essen, North Rhine-Westphalia, 45147, Germany

Location

Department of Nuclear Medicine, University Hospital Münster

Münster, North Rhine-Westphalia, 48149, Germany

Location

MeSH Terms

Conditions

Carcinoma, Intraductal, Noninfiltrating; Breast Neoplasms

Interventions

FAPI-46

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Breast Carcinoma In Situ; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Philipp Backhaus, Dr. med.

  Department of Nuclear Medicine, University Hospital Münster

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philipp Backhaus, Dr. med.

CONTACT

+4925183; nuklearmedizin@ukmuenster.de

Matthias Burg, Dr. med.

CONTACT

+4925183; radiologie@ukmuenster.de

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: August 6, 2024
• Study Start: September 10, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: August 6, 2024

Record last verified: 2024-02

Locations

DE (2)