Characterizing Breast Cancer With Al18F-NOTA-FAPI-04 PET/CT (PFB-02)
Accuracy and Safety of Al18F-NOTA-FAPI-04 PET/CT in the Diagnosis of Axillary Lymph Node Metastasis in Early Breast Cancer Patients: A Prospective Cohort Study
1 other identifier
interventional
88
1 country
1
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. Previous studies have demonstrated that FAPI PET/CT performs well in cases of epithelial tumors, including breast cancer. This prospective study is going to investigate the performance and value of Al18F-NOTA-FAPI-04 PET/CT in patients with breast cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable breast-cancer
Started May 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 10, 2022
CompletedFirst Submitted
Initial submission to the registry
October 7, 2022
CompletedFirst Posted
Study publicly available on registry
October 12, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2024
CompletedDecember 29, 2023
December 1, 2023
1.5 years
October 7, 2022
December 22, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Diagnostic Performance (1)
Diagnostic performance including sensitivity, specificity, accuracy, positive predictive value and negative predictive value of Al18F-NOTA-FAPI-04 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 Outcomes (3)
Clinical Stage
Through study completion, an average of 1 year
Diagnostic Performance (2)
Through study completion, an average of 1 year
Safety
Through study completion, an average of 1 year
Study Arms (1)
Al18F-NOTA-FAPI-04 PET/CT
EXPERIMENTALInject Al18F-NOTA-FAPI-04 and then perform PET/CT scan.
Interventions
Patients enrolled underwent PET/CT after injection of Al18F-NOTA-FAPI-04 to image lesions of breast cancer.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- pregnancy;
- breastfeeding;
- patients who were unwilling to undergo PET/CT scans.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Li Huo, M.D.
Peking Union Medical College Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 7, 2022
First Posted
October 12, 2022
Study Start
May 10, 2022
Primary Completion
October 31, 2023
Study Completion
February 1, 2024
Last Updated
December 29, 2023
Record last verified: 2023-12