68Ga-FAPI PET/CT in Pancreatic Ductal Carcinoma

March 2, 2022 updated by: Peking Union Medical College Hospital

A Prospective Pilot Study to Explore Performance and Efficacy of 68Ga-FAPI PET/CT in Pancreatic Ductal Carcinoma Patients

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

80

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

Study Contact Backup

  • Name: Li Huo, MD.
  • Phone Number: +86 13910801986
  • Email: huoli@pumch.cn

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Peking Union Medical College Hospita
        • Contact:

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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 examination
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.
Diagnostic test: 68Ga-FAPI Positron Emission Tomography-Computed Tomography
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Standard Uptake Value (SUV）
Time Frame: through study completion, an average of 0.5 year
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
Time Frame: through study completion, an average of 0.5 year
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
Time Frame: through study completion, an average of 0.5 year
Determination the lesions numbers were detected by 68Ga-FAPI
through study completion, an average of 0.5 year
Progression Free Survival (PFS)
Time Frame: through study completion, an average of 1 year
Determination the progression free survival of included patients
through study completion, an average of 1 year
Overall Survival (OS)
Time Frame: through study completion, an average of 2 year
Determination the overall survival of included patients
through study completion, an average of 2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Investigators

  • Principal Investigator: Li Huo, MD., 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 (Anticipated)

March 1, 2022

Primary Completion (Anticipated)

November 30, 2022

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

February 20, 2022

First Submitted That Met QC Criteria

March 2, 2022

First Posted (Actual)

March 11, 2022

Study Record Updates

Last Update Posted (Actual)

March 11, 2022

Last Update Submitted That Met QC Criteria

March 2, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PekingUMCH-FAPIPDAC

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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