Piloting 18F-FAPI PET/MRI for Applications in Breast Cancer

NCT ID: NCT07180433

Last Updated: 2025-09-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2038-12-31

Brief Summary

Breast cancer is the most common type of cancer in Norwegian women, with 4,224 new cases in 2022. More precise diagnosis are expected to result in more accurate assessment of treatment effect, and to contribute to both providing better treatment and reducing overtreatment. Fibroblast activating protein (FAP) is expressed in the tumor stroma of 90% of all epithelial-based tumors, including breast tumors. Inhibitors for this protein (FAPI) has been developed for use as radioactive tracers. Breast tumors of various histopathological types, and local metastatic lymph nodes, have shown high uptake for such tracers. The main aim of this project is to establish 18F-FAPI PET/MRI for use in breast cancer in a wide range of disease stages. We will evaluate how FAPI PET/MRI correlates with histopathological assessment, the method's ability to grade tumors - including assessment of treatment - compared to CT, scintigraphy and FDG PET/CT, and ability to detect local recurrence.

Conditions

Breast Neoplasm Female

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

FAPI-PET/MRI

The patients will be injected 2 MBq/kg 18F-FAPI, prior to PET/MRI acquisition

Group Type: EXPERIMENTAL

FAPI PET/MR

Intervention Type: DIAGNOSTIC_TEST

The patients will be injected intravenously with 2 MBq/kg 18F-FAPI, 60 minutes before the PET/MRI acquisition. The PET/MRI examinations will be performed on a Siemens Biograph mMR (Siemens Healthcare, Erlangen, Germany) with software version VE11P. Static PET will be acquired simultaneously with MRI using two protocols; a one bed position protocol in prone position covering the breast and a whole body 4-5 bed position protocol in supine position covering brain to thighs. Total acquisition time of the breast protocol will be approximately 20 minutes. Total acquisition time of the whole-body protocol will be approximately 30 minutes.

Interventions

FAPI PET/MR

The patients will be injected intravenously with 2 MBq/kg 18F-FAPI, 60 minutes before the PET/MRI acquisition. The PET/MRI examinations will be performed on a Siemens Biograph mMR (Siemens Healthcare, Erlangen, Germany) with software version VE11P. Static PET will be acquired simultaneously with MRI using two protocols; a one bed position protocol in prone position covering the breast and a whole body 4-5 bed position protocol in supine position covering brain to thighs. Total acquisition time of the breast protocol will be approximately 20 minutes. Total acquisition time of the whole-body protocol will be approximately 30 minutes.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

1. diagnosed with local invasive breast cancer,

2. scheduled for neoadjuvant therapy as primary treatment,

3. has recurrent or new breast cancer, or

4. scheduled for neoadjuvant therapy as primary treatment with FDG-PET/CT applied for staging.

Exclusion Criteria

• other primary malignancies than breast cancer, renal insufficiency or know allergy towards contrast agents, and MR incompatible implants.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Norwegian University of Science and Technology

OTHER

Sponsor Role: collaborator

St. Olavs Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

639856/23

Identifier Type: -

Identifier Source: org_study_id