18F-FDG Versus 68Ga-FAPI-46 as PET Tracer in ER-positive Breast Cancer.

Breast Cancer Clinical Trial

Official title:

18F-FDG Versus 68Ga-FAPI-46 as PET Tracer in ER-positive Breast Cancer - a Pilot Study.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06335069
• Other study ID #: 2023-508066-15-00
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: March 2024
• Est. completion date: March 2027

Study information

• Verified date: November 2023
• Source: Maastricht University Medical Center
• Contact: Thiemo JA van Nijnatten, MD, PhD
• Phone: +31433876910
• Email: thiemo.nijnatten[@]mumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: March 2027
• Est. primary completion date: March 2027
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Diseases
• Breast Neoplasms

Intervention

Diagnostic Test:
• 68Ga-FAPI-46 PET/CT and 68Ga-FAPI-46 PET/MRI
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.

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center+	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To investigate the accuracy of 68Ga-FAPI-46 compared to 18F-FDG as a radioactive PET tracer in patients with ER+ breast cancer.	The feasibility of using 68Ga-FAPI-46 as a tracer in terms of diagnostic accuracy will be compared per patient with 18F-FDG as a PET tracer.	Patients will be followed from diagnosis until the additional imaging exams are performed, within 20 working days both PET exams will be performed.
Secondary	To investigate the differences in accuracy between 68Ga-FAPI-46 PET/CT versus 68Ga-FAPI-46 PET/MRI.	Diagnostic performance will be compared between both exams (i.e. 68Ga-FAPI-46 PET/CT and 68Ga-FAPI-46 PET/MRI.	Patients will be followed from diagnosis until the additional imaging exams are performed, within 20 working days both PET exams will be performed.