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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05574907
Other study ID # PekingUMCH-FAPI-BC-1
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date May 1, 2021
Est. completion date February 1, 2024

Study information

Verified date December 2023
Source Peking Union Medical College Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 72
Est. completion date February 1, 2024
Est. primary completion date October 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - age 18-80 years old; - newly diagnosed BC confirmed by biopsy or with BI-RADS category 4C or 5 lesions by US or MG; - BC clinical stagecT1-3 cN0-3 M0; - no prior treatment for BC. Exclusion Criteria: - pregnancy; - breastfeeding; - patients who were unwilling to undergo PET/CT scans.

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
China Peking Union Medical College Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Diagnostic Performance (1) Diagnostic performance including sensitivity, specificity, accuracy, positive predictive value and negative predictive value of 68Ga-FAPI PET/CT in the detection of ALN metastasis according to the pathological reference standard on a per-patient basis, compared with 18F-FDG PET/CT and ultrasound. Through study completion, an average of 1 year
Secondary Clinical Stage Clinical stage changed by 68Ga-FAPI PET/CT compared to 18F-FDG PET/CT. Through study completion, an average of 1 year
Secondary Diagnostic Performance (2) Diagnostic performance of ALN metastasis of 68Ga-FAPI PET/CT with or without previous biopsy on breast lesion. Through study completion, an average of 1 year
Secondary Safety Short-term adverse effects (AEs) after 68Ga-FAPI injection. Through study completion, an average of 1 year
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