What is 68Ga-FAPI-46 studying for ER-positive breast cancer?

68Ga-FAPI-46 is being studied as a new PET tracer to detect cancer lesions in patients with ER-positive breast cancer. Researchers want to see if it finds more lesions than the standard tracer 18F-FDG, which could help with better staging and treatment decisions. This study is sponsored by Maastricht University Medical Center.

Who may be eligible for this breast cancer clinical trial?

Women aged 18 or older with estrogen receptor-positive breast cancer that is locally advanced, recurrent, or metastatic may be eligible. Participants must be willing and able to undergo additional imaging scans and provide informed consent. Please review eligibility criteria for more details.

Is there any cost to participate in this breast cancer clinical trial?

Study-related care, including the imaging scans and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 2

Age: 18Years +

FEMALE

ID06335069

18F-FDG Versus 68Ga-FAPI-46 as PET Tracer in ER-positive Breast Cancer - a Pilot Study

Led by Maastricht University Medical Center · Updated on 2025-09-24

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the diagnostic performance of two PET tracers, 18F-FDG and 68Ga-FAPI-46, in female patients with estrogen receptor-positive ER breast cancer. This pilot study focuses on patients with locally advanced, recurrent, or metastatic breast cancer and aims to determine if 68Ga-FAPI-46 detects more lesions than 18F-FDG, potentially leading to more accurate staging and treatment decisions. The study is sponsored by Maastricht University Medical Center and is conducted as a Phase 2 interventional trial. All participants will undergo an additional 68Ga-FAPI-46 PETCT and PETMRI scan before starting breast cancer treatment. These imaging exams will be performed within 20 working days from diagnosis and alongside the standard 18F-FDG PETCT or PETMRI scans. The study focuses on comparing these two diagnostic tracers accuracy in detecting cancer lesions in ER breast cancer patients. Participants will be followed from diagnosis until both PET exams are completed. The researchers will collect data to help calculate sample size for future studies and explore the feasibility of taking biopsies from lesions identified by the new tracer. Safety and ability to complete imaging procedures will be monitored. The total participation duration covers the time needed to conduct both imaging exams and any related assessments.

CONDITIONS

Brief Title

18F-FDG Versus 68Ga-FAPI-46 as PET Tracer in ER-positive Breast Cancer.

Who Can Participate

Age: 18Years +

FEMALE

Eligibility Criteria

You may qualify if you...

Female patient with histopathologically proven ER+ breast cancer
Diagnosed with locally advanced (primary tumor >5 cm and/or axillary lymph node metastases), recurrent, or metastatic breast cancer
Scheduled for 18F-FDG PET/CT or PET/MRI staging
Willing and able to undergo study procedures
Provided written informed consent

You will not qualify if you...

Younger than 18 years old
Pregnant
Having secondary cancers except non-melanoma skin cancer
No 18F-FDG PET/CT or PET/MRI scan available
Contraindications for PET/MRI such as pacemaker, aneurysm clips, metal implants, severe claustrophobia, or severe obesity
Chronic inflammatory diseases like rheumatoid arthritis
Severe liver or kidney impairment (eGFR 64 45 mL/min/1.73m8)
Unable to provide informed consent

Research Team

Thiemo JA van Nijnatten, MD, PhD

Lisa EHW Duijx, MSc

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