Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06335069
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-28
First Post:
2024-03-11
Brief Title:
18F-FDG Versus 68Ga-FAPI-46 as PET Tracer in ER-positive Breast Cancer
Sponsor:
Maastricht University Medical Center
Organization:
Maastricht University Medical Center
Study Overview
Official Title:
18F-FDG Versus 68Ga-FAPI-46 as PET Tracer in ER-positive Breast Cancer - a Pilot Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The extent of breast cancer is an important prognostic factor in patients diagnosed with this disease Therefore adequate staging at diagnosis is a requisite for optimal treatment In all patients diagnosed with locally advanced breast cancer LABC distant staging using 18F-FDG PETCT is recommended However the degree of metabolic uptake in the primary breast tumor is significantly lower in the ER subtype compared to HER2 and triple negative breast cancer TNBC As a consequence a suboptimal 18F-FDG uptake in ER breast cancer patients can potentially lead to missed distant metastases Fibroblast-activating protein inhibitor FAPI is a recently developed radiotracer that binds to FAP a stromal antigen overexpressed in more than 90 of epithelial-derived tumors and their metastases Previous studies all show 68Ga-FAPI PETCT to have a higher detection rate compared to 18F-FDG PETCT However all previous studies were performed without considering breast cancer subtype If the metabolic uptake by 68Ga-FAPI-46 is higher in ER breast cancer patients more lesions will be detected resulting in a more appropriate treatment for these patients Therefore in this pilot study the investigators aim to compare the diagnostic performance of 18F-FDG with 68Ga-FAPI-46 as PET-tracer in ER breast cancer patients
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None