- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05574907
Characterizing Breast Cancer With 68Ga-FAPI PET/CT (PFB-01)
December 22, 2023 updated by: Peking Union Medical College Hospital
Accuracy and Safety of 68Ga-FAPI PET/CT in the Diagnosis of Axillary Lymph Node Metastasis in Early Breast Cancer Patients: A Prospective Cohort Study
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
72
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Zhixin Hao, M.D.
- Phone Number: +86-18401649136
- Email: zxhaonm@outlook.com
Study Contact Backup
- Name: Li Huo, M.D.
- Phone Number: +86-13910801986
- Email: huoli@pumch.cn
Study Locations
-
-
Beijing
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Beijing, Beijing, China, 100730
- Peking Union Medical College Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 68Ga-FAPI PET/CT
Inject 68Ga-FAPI and then perform 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diagnostic Performance (1)
Time Frame: Through study completion, an average of 1 year
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Stage
Time Frame: Through study completion, an average of 1 year
|
Clinical stage changed by 68Ga-FAPI PET/CT compared to 18F-FDG PET/CT.
|
Through study completion, an average of 1 year
|
Diagnostic Performance (2)
Time Frame: Through study completion, an average of 1 year
|
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
|
Safety
Time Frame: Through study completion, an average of 1 year
|
Short-term adverse effects (AEs) after 68Ga-FAPI injection.
|
Through study completion, an average of 1 year
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Compared with 18F-FDG PET/CT
Time Frame: 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
|
through study completion, an average of 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Li Huo, M.D., Peking Union Medical College Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2021
Primary Completion (Actual)
October 31, 2023
Study Completion (Estimated)
February 1, 2024
Study Registration Dates
First Submitted
October 7, 2022
First Submitted That Met QC Criteria
October 10, 2022
First Posted (Actual)
October 12, 2022
Study Record Updates
Last Update Posted (Actual)
December 29, 2023
Last Update Submitted That Met QC Criteria
December 22, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PekingUMCH-FAPI-BC-1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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