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Trial Title:
18F-FDG Versus 68Ga-FAPI-46 as PET Tracer in ER-positive Breast Cancer.
NCT ID:
NCT06335069
Condition:
Breast Cancer
Breast Neoplasms
Breast Diseases
Conditions: Official terms:
Breast Neoplasms
Breast Diseases
FAPI-46
Conditions: Keywords:
68Ga-FAPI-46
ER+ breast cancer
PET/CT
PET/MRI
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Single-group, single-center pilot study
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
68Ga-FAPI-46 PET/CT and 68Ga-FAPI-46 PET/MRI
Description:
All participating patients will undergo an additional 68Ga-FAPI- 46 PET/CT and
68Ga-FAPI-46 PET/MRI scan prior to their breast cancer treatment.
Arm group label:
Additional 68Ga-FAPI-46 PET/CT and PET/MRI exam
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 PET/CT 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 PET/CT to have a higher
detection rate compared to 18F-FDG PET/CT. 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.
Criteria for 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.
Gender:
Female
Gender based:
Yes
Gender description:
Only females are eligible to participate in this study.
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Maastricht University Medical Center+
Address:
City:
Maastricht
Zip:
5800
Country:
Netherlands
Contact:
Last name:
Thiemo JA van Nijnatten, MD, PhD
Email:
thiemo.nijnatten@mumc.nl
Start date:
March 2024
Completion date:
March 2027
Lead sponsor:
Agency:
Maastricht University Medical Center
Agency class:
Other
Source:
Maastricht University Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06335069
