Evaluating the Potential Usefulness of 18F-AlF-FAPI PET/CT in Patients With Gastrointestinal Tumors and Compared With 18F-FDG PET/CT

Sponsor
The First Affiliated Hospital of Xiamen University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05430841
Collaborator
(none)
100
1
1
19
5.3

Study Details

Study Description

Brief Summary

To evaluate the potential usefulness of 18F-AlF-FAPI positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in gastrointestinal tumors, and compared with 18F-FDG PET/CT.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: 18F-FDG, 18F-AlF-FAPI PET/CT
N/A

Detailed Description

Subjects with gastrointestinal tumors underwent contemporaneous 18F-AlF-FAPI and 18F-FDG PET/CT either for an initial assessment or for recurrence detection. Tumor uptake was quantified by the maximum standard uptake value (SUVmax). The numbers of positive tumor lesions of 18F-FDG and 18F-AlF-FAPI PET/CT were recorded by visual interpretation. The sensitivity, specificity, and accuracy of 18F-AlF-FAPI, 18F-FDG PET/CT were calculated and compared to evaluate the diagnostic accuracy.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Evaluating the Potential Usefulness of 18F-AlF-FAPI PET/CT in Patients With Gastrointestinal Tumors and Compared With 18F-FDG PET/CT
Actual Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: 18F-AlF-FAPI PET/CT

Each subject receives a single intravenous injection of 18F-FDG and 18F-AlF-FAPI, and undergo PET/CT imaging within the specified time.

Diagnostic Test: 18F-FDG, 18F-AlF-FAPI PET/CT
Each subject receives a single intravenous injection of 18F-FDG and 18F-AlF-FAPI, and undergo PET/CT imaging within the specified time.

Outcome Measures

Primary Outcome Measures

  1. Diagnostic accuracy [30 days]

    The sensitivity, specificity, and accuracy of 18F-FDG and 18F-AlF-FAPI PET/CT were calculated and compared to evaluate the diagnostic efficacy.

Secondary Outcome Measures

  1. SUV [7 days]

    Standardized uptake value (SUV) of 18F-FDG and 18F-AlF-FAPI PET/CT for each target lesion of subject or suspected primary tumor or/and metastasis.

  2. Number of lesions [7 days]

    The numbers of positive primary and metastatic lesions of 18F-FDG and 18F-AlF-FAPI PET/CT were recorded by visual interpretation.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • adult patients (aged 18 years or order);

  • patients with suspected or newly diagnosed or previously treated gastrointestinal tumors (supporting evidence may include MRI, CT, tumor markers and pathology report);

  • patients who had scheduled both 18F-FDG and 18F-AlF-FAPI PET/CT scans;

  • patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

Exclusion Criteria:
  • patients with non-malignant lesions;

  • patients with pregnancy;

  • the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.

Contacts and Locations

Locations

Site City State Country Postal Code
1 The First affiliated hospital of xiamen university Xiamen Fujian China 361000

Sponsors and Collaborators

  • The First Affiliated Hospital of Xiamen University

Investigators

  • Study Chair: Long Sun, PhD, The First Affiliated Hospital of Xiamen University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
The First Affiliated Hospital of Xiamen University
ClinicalTrials.gov Identifier:
NCT05430841
Other Study ID Numbers:
  • XMYY-2021KY061
First Posted:
Jun 24, 2022
Last Update Posted:
Jun 24, 2022
Last Verified:
Jun 1, 2022
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
Keywords provided by The First Affiliated Hospital of Xiamen University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 24, 2022