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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
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for PDAC

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients with suspected pancreatic lesions
  2. Signed written consent.

Exclusion Criteria:

  1. pregnancy;
  2. breastfeeding;
  3. 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

First Posted
February 20, 2022
Last Updated
March 2, 2022
Sponsor
Peking Union Medical College Hospital
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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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