68Ga-FAPI PET/CT in Pancreatic Ductal Carcinoma
A Prospective Pilot Study to Explore Performance and Efficacy of 68Ga-FAPI PET/CT in Pancreatic Ductal Carcinoma Patients
1 other identifier
interventional
80
1 country
1
Brief Summary
Fibroblast activation protein (FAP) is overexpressed in cancer-associated fibroblasts (CAFs), which constitutes a major proportion of cells within the tumor microenvironment, especially in primary pancreatic ductal carcinoma (PDAC). In this prospective study, we aimed to evaluate the performance and value of 68Ga-FAPI-04 PET/CT in the patients with PDAC.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 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
First Submitted
Initial submission to the registry
February 20, 2022
CompletedStudy Start
First participant enrolled
March 1, 2022
CompletedFirst Posted
Study publicly available on registry
March 11, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2023
CompletedMarch 11, 2022
March 1, 2022
9 months
February 20, 2022
March 2, 2022
Conditions
Outcome Measures
Primary Outcomes (5)
Standard Uptake Value (SUV）
Determined and compared the SUV for detected lesions in 68Ga-FAPI
through study completion, an average of 0.5 year
The numbers of patients who been changed the treatment methods
Determination the patients numbers who been changed the treatment methods after 68Ga-FAPI PET
through study completion, an average of 0.5 year
The numbers of lesions
Determination the lesions numbers were detected by 68Ga-FAPI
through study completion, an average of 0.5 year
Progression Free Survival (PFS)
Determination the progression free survival of included patients
through study completion, an average of 1 year
Overall Survival (OS)
Determination the overall survival of included patients
through study completion, an average of 2 year
Study Arms (1)
68Ga-FAPI PET/CT examination
EXPERIMENTALPatients with suspected pancreatic lesions underwent 68Ga-FAPI PET/CT to distinguish benign and malignant lesions, to evaluate the resectability of lesions and to detect distant metastasis. The clinicians decided the treatment methods based on the results of 68Ga-FAPI PET/CT.
Interventions
The patients with suspected pancreatic lesions were included. They underwent 68Ga-FAPI PET/CT to distinguish benign and malignant lesions, to evaluate the resectability of lesions and to detect distant metastasis. The treatment methods were decided according to the results of 68Ga-FAPI PET/CT.
Eligibility Criteria
You may qualify if:
- Patients with suspected pancreatic lesions
- Signed written consent.
You may not qualify if:
- pregnancy;
- breastfeeding;
- any medical condition that in the opinion of the investigator may significantly interfere with study compliance
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking Union Medical College Hospita
Beijing, Beijing Municipality, 100730, China
Study Officials
- PRINCIPAL INVESTIGATOR
Li Huo, MD.
Peking Union Medical College Hospital
Central Study Contacts
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
February 20, 2022
First Posted
March 11, 2022
Study Start
March 1, 2022
Primary Completion
November 30, 2022
Study Completion
June 1, 2023
Last Updated
March 11, 2022
Record last verified: 2022-03