Clinical trial NCT06335069: 18F-FDG Versus 68Ga-FAPI-46 as PET Tracer in ER-positive Breast Cancer.
Official title: 18F-FDG Versus 68Ga-FAPI-46 as PET Tracer in ER-positive Breast Cancer - a Pilot Study.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Breast Cancer
Breast Neoplasms
Breast Diseases
Keywords: 68Ga-FAPI-46
ER+ breast cancer
PET/CT
PET/MRI
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2024-03-28
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-group, single-center pilot study
Primary purpose: DIAGNOSTIC

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 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.


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.

Primary outcomes:
measure: To investigate the accuracy of 68Ga-FAPI-46 compared to 18F-FDG as a radioactive PET tracer in patients with ER+ breast cancer.
timeFrame: Patients will be followed from diagnosis until the additional imaging exams are performed, within 20 working days both PET exams will be performed.
Secondary outcomes:
measure: To investigate the differences in accuracy between 68Ga-FAPI-46 PET/CT versus 68Ga-FAPI-46 PET/MRI.
timeFrame: Patients will be followed from diagnosis until the additional imaging exams are performed, within 20 working days both PET exams will be performed.
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center+
Study officials:
References: