Study of 18F-FAPI Applied to Gastrointestinal Cancer

• Sponsor: First Affiliated Hospital Xi'an Jiaotong University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05788874
• Collaborator: (none)
• Enrollment: 50
• Anticipated Duration (Months): 21.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Gastrointestinal Cancer	Diagnostic Test: 18F-FAPI and 18F-FDG PET/CT

Study Design

• Study Type: Observational
• Anticipated Enrollment: 50 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Comparative Study of 18F-FAPI and 18F-FDG PET/CT for Gastrointestinal Cancer
• Anticipated Study Start Date: Mar 1, 2023
• Anticipated Primary Completion Date: Jun 1, 2024
• Anticipated Study Completion Date: Dec 1, 2024

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. SUVmax [1 day (During the inspection)]

   Measurement of the maximum standardized uptake value of the lesion

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• First Affiliated Hospital Xi'an Jiaotong University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: First Affiliated Hospital Xi'an Jiaotong University
• ClinicalTrials.gov Identifier: NCT05788874
• Other Study ID Numbers: XJTU1AF-CRF-2022-021
• First Posted: Mar 29, 2023
• Last Update Posted: Mar 29, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Gastrointestinal Neoplasms; Fluorodeoxyglucose F18

Study Results

No Results Posted as of Mar 29, 2023