18F-FDG versus 68Ga-FAPI-46 as PET tracer in ER-positive breast cancer - a pilot study

Phase 2

Not yet recruiting

• Conditions: Hormone-positive breast cancer

• Registration Number: 2023-508066-15-01
• Lead Sponsor: University Hospital Maastricht

Brief Summary

The aim of this pilot study is to determine essential input parameters for an adequate sample size calculation for a diagnostic study that compares the diagnostic accuracy of 18F-FDG and 68Ga-FAPI-46 as PET-tracer in patients with ER+ breast cancer.

Detailed Description

Not available

Study Timeline

• Study First Posted: 2025-03-18
• Last Update Posted: 2025-06-23

Recruitment & Eligibility

• Status: Authorised, recruitment pending
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

Female patient with histopathologically proven ER+ breast cancer.

Diagnosed with locally advanced breast cancer (primary tumor >5 cm and/or presence of axillary lymph node metastases) or recurrent breast cancer, or metastatic breast cancer for which 18F-FDG PET/CT or 18F-FDG PET/MRI staging is performed.

Willing and able to undergo the study procedures.

Has personally provided written informed consent.

Exclusion Criteria

Age <18.

Pregnancy.

Patients with secondary malignancies (except non-melanoma skin cancer).

No 18F-FDG PET/CT or 18F-FDG PET/MRI scan.

Contra-indications for PET/MRI such as pacemaker, aneurysm clips, metallic device in their body, severe claustrophobia, and severe obesity

Inability to provide informed consent.

Chronic inflammatory disease such as rheumatoid arthritis.

Patients with severe hepatic or renal impairment (eGFR ≤45mL/min/1.73m²)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The proportion of discordant pairs: How many lesions are detected on the 68Ga-FAPI-46 PET scan but not on the 18F-FDG PET scan and how many lesions are detected on the 18F-FDG PET scan but not on the 68Ga-FAPI-46 PET scan?		The proportion of discordant pairs: How many lesions are detected on the 68Ga-FAPI-46 PET scan but not on the 18F-FDG PET scan and how many lesions are detected on the 18F-FDG PET scan but not on the 68Ga-FAPI-46 PET scan?

Secondary Outcome Measures

Name	Time	Method
To investigate the proportion of 68Ga-FAPI-46-positive 18F-FDG-negative lesions for which performing a biopsy is not feasible.		To investigate the proportion of 68Ga-FAPI-46-positive 18F-FDG-negative lesions for which performing a biopsy is not feasible.

Trial Locations

Locations (1)

Maastricht University Medical Center; 🇳🇱 Maastricht, Netherlands

Maastricht University Medical Center

🇳🇱Maastricht, Netherlands

Thiemo van Nijnatten

Site contact

+31433876910

thiemo.nijnatten@mumc.nl