Actively Recruiting
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
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
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 PET/CT and PET/MRI scan before starting breast cancer treatment. These imaging exams will be performed within 20 working days from diagnosis and alongside the standard 18F-FDG PET/CT or PET/MRI 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
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Within 20 working days
Participants undergo additional 68Ga-FAPI-46 PET/CT and PET/MRI scans prior to their breast cancer treatment.
2 imaging visits (in-person)
Trial Site Locations
Total: 1 location
1
Maastricht University Medical Center+
Maastricht, Netherlands, 5800
Actively Recruiting
Research Team
T
Thiemo JA van Nijnatten, MD, PhD
L
Lisa EHW Duijx, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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