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

NCT07180433 | Not Yet Recruiting

• 1 other identifier: 639856/23
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of 18F-FAPI-PET/MRI in detection of breast cancer lesions

  Diagnostic accuracy (sensitivity, specificity, positive predictive value, negative predictive value) of 18F-FAPI-PET/MRI in detecting breast cancer lesions, including primary tumors, regional lymph node metastases, distant metastases, and local/distant recurrences. Interpretation will be based on consensus assessment by nuclear medicine physicians and radiologists. Histopathology and/or conventional imaging (CT, FDG-PET, bone scintigraphy) will serve as the reference standards.

  Baseline

Secondary Outcomes (5)

• Correlation of standardized uptake values of 18F-FAPI to histologically proven characteristics of the breast cancer lesions

  Baseline

• Diagnostic accuracy of 18F-FAPI PET/MR compared to MR only in prediction/evaluation of response to neoadjuvant chemotherapy

  From baseline to surgery (~3-6 months)

• Diagnostic accuracy of 18F-FAPI PET/MR compared to standard CT/bone scintigraphy in staging of breast cancer

  Baseline

• Diagnostic accuracy of 18F-FAPI PET/MR compared to CT/bone scintigraphy in detection of recurrence.

  Baseline

• Diagnostic accuracy of 18F-FAPI PET/MR compared to 18F-FDG PET/CT.

  Baseline

Study Arms (1)

FAPI-PET/MRI

EXPERIMENTAL

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

Diagnostic Test: FAPI PET/MR

Interventions

FAPI PET/MR 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.

FAPI-PET/MRI

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosed with local invasive breast cancer,
• scheduled for neoadjuvant therapy as primary treatment,
• has recurrent or new breast cancer, or
• scheduled for neoadjuvant therapy as primary treatment with FDG-PET/CT applied for staging.

You may not qualify if:

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

Sponsors & Collaborators

• St. Olavs Hospital: lead
• Norwegian University of Science and Technology: collaborator

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2025
• First Posted: September 18, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2038
• Last Updated: September 18, 2025

Record last verified: 2025-09