A Study Using 18F-FAPI PET to Evaluate Treatment Response in Pancreatic Adenocarcinoma

February 23, 2024 updated by: TingBo Liang, Zhejiang University

A Study Using 18F-FAPI PET to Evaluate Pathologic Response to Systemic Treatment in Pancreatic Adenocarcinoma

To explore the potential utility of 18F-FAPI-04 PET/CT for pathologic response evaluation to systemic treatment in PDAC

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

59

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • First Affiliated Hospital, Medical College of Zhejiang University

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Pancreatic cancer patients with resectable, borderline or locally advanced disease who plan to undergo systemic treatment, including chemotherpy or chemoimmunotherapy

Description

Inclusion Criteria:

  • suspected to have pancreatic cancer by radiological imaging
  • planned systemic treatment
  • possibility of conversion surgery
  • willingness to participate the study

Exclusion Criteria:

  • without pathologically confirmed pancreatic cancer
  • poor performance status or organ functions that cannot meet the systemic treatment requirements
  • metastatic disease
  • pregnant patients

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Maximum standardized uptake value
Time Frame: Baseline and preoperation
Change of SUVmax before and after treatment
Baseline and preoperation
Change of Mean standardized uptake value
Time Frame: Baseline and preoperation
Change of SUVmean before and after treatment
Baseline and preoperation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum standardized uptake value
Time Frame: Baseline
Baseline SUVmax at diagnosis
Baseline
Mean standardized uptake value
Time Frame: Baseline
Baseline SUVmean at diagnosis
Baseline
Metabolic Tumor Volume
Time Frame: Baseline
Baseline MTV at diagnosis
Baseline
Total Lesion FAP expression
Time Frame: Baseline
Baseline TLF at diagnosis
Baseline
Change of Metabolic Tumor Volume
Time Frame: Baseline and preoperation
Change of MTV before and after treatment
Baseline and preoperation
Change of Total Lesion FAP expression
Time Frame: Baseline and preoperation
Change of TLF before and after treatment
Baseline and preoperation

Collaborators and Investigators

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

Sponsor

Zhejiang University

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 (Actual)

August 4, 2021

Primary Completion (Actual)

November 19, 2023

Study Completion (Actual)

February 10, 2024

Study Registration Dates

First Submitted

February 17, 2024

First Submitted That Met QC Criteria

February 23, 2024

First Posted (Estimated)

February 26, 2024

Study Record Updates

Last Update Posted (Estimated)

February 26, 2024

Last Update Submitted That Met QC Criteria

February 23, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FAPIPDAC02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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