68Ga-FAPI PET/CT in Pancreatic Ductal Carcinoma
Primary Purpose
PDAC
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
68Ga-FAPI Positron Emission Tomography-Computed Tomography
Sponsored by
About this trial
This is an interventional diagnostic trial for PDAC
Eligibility Criteria
Inclusion Criteria:
- Patients with suspected pancreatic lesions
- Signed written consent.
Exclusion Criteria:
- pregnancy;
- breastfeeding;
- any medical condition that in the opinion of the investigator may significantly interfere with study compliance
Sites / Locations
- Peking Union Medical College HospitaRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
68Ga-FAPI PET/CT examination
Arm Description
Patients 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.
Outcomes
Primary Outcome Measures
Standard Uptake Value (SUV)
Determined and compared the SUV for detected lesions in 68Ga-FAPI
The numbers of patients who been changed the treatment methods
Determination the patients numbers who been changed the treatment methods after 68Ga-FAPI PET
The numbers of lesions
Determination the lesions numbers were detected by 68Ga-FAPI
Progression Free Survival (PFS)
Determination the progression free survival of included patients
Overall Survival (OS)
Determination the overall survival of included patients
Secondary Outcome Measures
Full Information
NCT ID
NCT05275985
First Posted
February 20, 2022
Last Updated
March 2, 2022
Sponsor
Peking Union Medical College Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05275985
Brief Title
68Ga-FAPI PET/CT in Pancreatic Ductal Carcinoma
Official Title
A Prospective Pilot Study to Explore Performance and Efficacy of 68Ga-FAPI PET/CT in Pancreatic Ductal Carcinoma Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Anticipated)
Primary Completion Date
November 30, 2022 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
Detailed Description
With an incidence rate of 10 cases per 100,000 people per year, cancer of the pancreas is the third most common malignancy of the gastrointestinal tract. The overall survival for patients with pancreatic cancer is very poor, with a 5-year survival of 1% to 4%. Successful therapy depends on early diagnosis. The discrimination between benign and malignancies of the pancreas and the assessment of local resectability and distant metastases of the pancreatic cancer remains challenging with different imaging modalities such as ultrasound (US), endoscopic US (EUS), multidetector row computed tomography (MDCT), magnetic resonance imaging (MRI), and 18F-FDG positron emission tomography (PET). PDAC is characterized by a distinct and exuberant desmoplastic stroma, with stromal components outnumbering the pancreatic cancer cells. In PDAC, more than 90% of the tumour volume consists of cancer-associated fibroblasts (CAF). Fibroblast activation protein (FAP) is highly and selectively expressed in CAFs but is weakly expressed or not detected in normal tissues. The aim of this study was to evaluate the impact of FAPI-PET/CT on the clinical management of patients with suspected pancreatic cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PDAC
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
68Ga-FAPI PET/CT examination
Arm Type
Experimental
Arm Description
Patients 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.
Intervention Type
Diagnostic Test
Intervention Name(s)
68Ga-FAPI Positron Emission Tomography-Computed Tomography
Intervention Description
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.
Primary Outcome Measure Information:
Title
Standard Uptake Value (SUV)
Description
Determined and compared the SUV for detected lesions in 68Ga-FAPI
Time Frame
through study completion, an average of 0.5 year
Title
The numbers of patients who been changed the treatment methods
Description
Determination the patients numbers who been changed the treatment methods after 68Ga-FAPI PET
Time Frame
through study completion, an average of 0.5 year
Title
The numbers of lesions
Description
Determination the lesions numbers were detected by 68Ga-FAPI
Time Frame
through study completion, an average of 0.5 year
Title
Progression Free Survival (PFS)
Description
Determination the progression free survival of included patients
Time Frame
through study completion, an average of 1 year
Title
Overall Survival (OS)
Description
Determination the overall survival of included patients
Time Frame
through study completion, an average of 2 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with suspected pancreatic lesions
Signed written consent.
Exclusion Criteria:
pregnancy;
breastfeeding;
any medical condition that in the opinion of the investigator may significantly interfere with study compliance
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jie Ding, MD.
Phone
+86 17810259215
Email
707462902@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Li Huo, MD.
Phone
+86 13910801986
Email
huoli@pumch.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li Huo, MD.
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking Union Medical College Hospita
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Huo, MD.
Phone
+86 13910801986
Email
huoli@pumch.cn
12. IPD Sharing Statement
Learn more about this trial
68Ga-FAPI PET/CT in Pancreatic Ductal Carcinoma
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