18F-FDG Versus 68Ga-FAPI-46 as PET Tracer in ER-positive Breast Cancer.
Launched by MAASTRICHT UNIVERSITY MEDICAL CENTER · Mar 21, 2024
Trial Information
Current as of June 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying two different imaging techniques, 18F-FDG and 68Ga-FAPI-46, to see which one works better at detecting the spread of estrogen receptor-positive (ER+) breast cancer. Properly identifying how far the cancer has spread is crucial for determining the best treatment options for patients. The researchers believe that 68Ga-FAPI-46 might detect more cancer lesions in ER+ breast cancer patients than the traditional 18F-FDG method, which could lead to more effective treatment plans.
To be eligible for this study, participants must be women diagnosed with locally advanced or recurrent ER+ breast cancer. They should be willing to undergo specific imaging tests and provide written consent to participate. Participants can expect to receive either of the two imaging tests during the study, helping researchers figure out which method is more effective for this type of cancer. This trial is not yet recruiting, but it aims to improve cancer detection and treatment for women facing ER+ breast cancer in the future.
Gender
FEMALE
Eligibility criteria
- Inclusion Criteria:
- • Female patient with histopathologically proven ER+ breast cancer.
- • Diagnosed with locally advanced (primary tumor \>5 cm and/or presence of axillary lymph node metastases) or recurrent 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
- • 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
- • Chronic inflammatory disease such as rheumatoid arthritis.
- • Patients with severe hepatic or renal impairment (eGFR ≤45mL/min/1.73m²)
- • Inability to provide informed consent.
About Maastricht University Medical Center
Maastricht University Medical Center (MUMC+) is a leading academic medical center in the Netherlands, renowned for its commitment to advancing healthcare through innovative research and education. As a prominent sponsor of clinical trials, MUMC+ integrates cutting-edge scientific inquiry with clinical practice, focusing on a wide range of medical disciplines. The center emphasizes collaboration among multidisciplinary teams, fostering an environment that promotes excellence in patient care and the translation of research findings into clinical applications. MUMC+ is dedicated to improving health outcomes and enhancing quality of life through rigorous clinical investigations and the development of novel therapeutic strategies.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Maastricht, , Netherlands
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported