18F-FDG versus 68Ga-FAPI-46 as PET tracer in ER-positive breast cancer - a pilot study
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- University Hospital Maastricht
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- 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.
- Status
- Recruiting
- Last Updated
- 7 months ago
Overview
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.
Investigators
T.J.A. van Nijnatten
Scientific
University Hospital Maastricht
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, 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
- •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
- •Chronic inflammatory disease such as rheumatoid arthritis.
- •Patients with severe hepatic or renal impairment (eGFR ≤45mL/min/1.73m²)
- •Inability to provide informed consent.
Outcomes
Primary Outcomes
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.
Time Frame: Patients will be followed from diagnosis until the additional imaging exams are performed, within 20 working days both PET exams will be performed.
To investigate the proportion of discordant pairs: the number of lesions detected on 18F-FDG PET but not on 68Ga-FAPI-46 PET and the number of lesions detected on 68Ga-FAPI-46 PET but not on 18F-FDG PET.
Secondary Outcomes
- To explore the feasibility of taking biopsies in test-positive patients.(Patients will be followed from diagnosis until the additional imaging exams are performed, within 20 working days both PET exams will be performed.)