NCT05788874

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 29, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

April 14, 2023

Status Verified

April 1, 2023

Enrollment Period

1.1 years

First QC Date

March 16, 2023

Last Update Submit

April 12, 2023

Conditions

Gastrointestinal Cancer

Outcome Measures

Primary Outcomes (1)

  • SUVmax

    Measurement of the maximum standardized uptake value of the lesion

    1 day (During the inspection)

Study Arms (2)

18F-FDG

Diagnostic Test: 18F-FAPI and 18F-FDG PET/CT

18F-FAPI

Diagnostic Test: 18F-FAPI and 18F-FDG PET/CT

Interventions

18F-FAPI and 18F-FDG PET/CTDIAGNOSTIC_TEST

18F-FAPI and 18F-FDG PET/CT for gastrointestinal cancer

18F-FAPI18F-FDG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal Diseases

Central Study Contacts

Yan Li

CONTACT

0086-1582936442929396779@qq.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2023

First Posted

March 29, 2023

Study Start

May 1, 2023

Primary Completion

June 1, 2024

Study Completion

December 1, 2024

Last Updated

April 14, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share