Study of 18F-FAPI Applied to Gastrointestinal Cancer

April 12, 2023 updated by: First Affiliated Hospital Xi'an Jiaotong University

Comparative Study of 18F-FAPI and 18F-FDG PET/CT for Gastrointestinal Cancer

Comparison of tumor volume, number, and SUVmax of different primary foci (gastric, duodenal, and colon cancer), lymph node metastases (neck and supraclavicular, mediastinal, abdominal, and pelvic), and distant metastases (brain, lung, liver, bone, pleura, and peritoneum) detected by 18F-FAPI versus 18F-FDG PET/CT imaging.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

50

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

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

Yes

Sampling Method

Probability Sample

Study Population

  • Patients with high clinical suspicion of gastrointestinal tumor and negative 18F-FDG at first diagnosis
  • Post-treatment patients with high clinical suspicion of recurrence or metastasis and negative 18F-FDG

Description

Inclusion Criteria:

  • Patients with high clinical suspicion of gastrointestinal tumor and negative 18F-FDG at first diagnosis
  • Post-treatment patients with high clinical suspicion of recurrence or metastasis and negative 18F-FDG

Exclusion Criteria:

  • The diagnosis can be clarified by 18F-FDG PET/CT examination
  • The presence of recurrence or metastasis can be clarified by 18F-FDG PET/CT examination

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
18F-FDG
Diagnostic test: 18F-FAPI and 18F-FDG PET/CT
18F-FAPI and 18F-FDG PET/CT for gastrointestinal cancer
18F-FAPI
Diagnostic test: 18F-FAPI and 18F-FDG PET/CT
18F-FAPI and 18F-FDG PET/CT for gastrointestinal cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SUVmax
Time Frame: 1 day (During the inspection)
Measurement of the maximum standardized uptake value of the lesion
1 day (During the inspection)

Collaborators and Investigators

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

Sponsor

First Affiliated Hospital Xi'an Jiaotong 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 (Anticipated)

May 1, 2023

Primary Completion (Anticipated)

June 1, 2024

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

March 16, 2023

First Submitted That Met QC Criteria

March 28, 2023

First Posted (Actual)

March 29, 2023

Study Record Updates

Last Update Posted (Actual)

April 14, 2023

Last Update Submitted That Met QC Criteria

April 12, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJTU1AF-CRF-2022-021

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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