Characterizing Breast Cancer With 68Ga-FAPI PET/CT
Study Details
Study Description
Brief Summary
Fibroblast activation protein (FAP) is overexpressed in cancer-associated fibroblasts (CAFs), which constitute a major proportion of cells within the tumor microenvironment, especially in breast cancer. 68Ga-FAPI has been developed as a tumor-targeting agent. This prospective study is going to investigate the performance and value of 68Ga- FAPI PET/CT in patients with breast cancer.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Breast cancer is a complex, heterogeneous disease comprising numerous distinct biological subtypes characterized by variant pathobiological features and clinical behaviors. 18F-fluorodeoxyglucose (18F-FDG) PET/CT, an essential imaging modality in the characterization of metabolism within the tumor, has successfully evolved in the diagnosis, staging, and assessment of treatment response in patients with breast cancer. Cancer-associated fibroblasts (CAFs) are a crucial component of the tumor stroma with diverse functions. Fibroblast activation protein (FAP), a type II membrane-bound glycoprotein from the dipeptidyl peptidase-4 family, is highly expressed in the CAFs of several epithelial carcinomas, including breast cancer, coupled with relatively low expression in normal tissue. Gallium-68 (68Ga)-conjugated FAP inhibitor (FAPI), a new radiotracer targeting FAP, has been developed for targeting FAP and tumor-stromal visualization. With its fast renal clearance and high tumor-to-background ratio, 68Ga-FAPI has been successfully validated in multi-types of tumors. This study aims to evaluate the performance and value of 68Ga- FAPI PET/CT in patients with breast cancer.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 68Ga-FAPI PET/CT Inject 68Ga-FAPI and then perform PET/CT scan. |
Diagnostic Test: 68Ga-FAPI PET/CT scan
Patients with suspected breast cancer underwent 68Ga-FAPI PET/CT after an injection of 74-148 MBq (2-4 mCi) 68Ga-FAPI to image lesions of breast cancer.
|
Outcome Measures
Primary Outcome Measures
- SUVmax was measured in the breast cancer lesions on 68Ga-FAPI PET/CT. [through study completion, an average of 1 year]
Standardized uptake value of 68Ga-FAPI in BC
- Standardized uptake value of 68Ga-FAPI in BC [through study completion, an average of 1 year]
The mean standard uptake value SUVmean was measured in the breast cancer lesions on 68Ga-FAPI PET/CT.
Secondary Outcome Measures
- Lesions detected by 68Ga-FAPI PET/CT [through study completion, an average of 1 year]
The number of target lesions in each organ system was calculated by 68Ga-FAPI PET/CT.
Other Outcome Measures
- Compared with 18F-FDG PET/CT [through study completion, an average of 1 year]
The number of lesions detected by 68Ga-FAPI PET/CT was compared with 18F-FDG PET/CT.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
suspected or confirmed untreated breast cancer;
-
18F-FDG PET/CT within two weeks;
-
signed written consent.
Exclusion Criteria:
-
pregnancy;
-
breastfeeding;
-
any medical condition that in the opinion of the investigator may significantly interfere with study compliance.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Peking Union Medical College Hospital | Beijing | Beijing | China | 100730 |
Sponsors and Collaborators
- Peking Union Medical College Hospital
Investigators
- Principal Investigator: Li Huo, M.D., Peking Union Medical College Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PekingUMCH-FAPI-BC-1