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

Xiamen University logo

Xiamen University

Status

Completed

Conditions

Gastric Cancer
Liver Cancer
Pancreatic Cancer

Treatments

Diagnostic Test: 18F-FDG, 18F-AlF-FAPI PET/CT

Study type

Interventional

Funder types

Other

Identifiers

NCT05430841
XMYY-2021KY061

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

120 participants in 1 patient group

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

Trial contacts and locations

1

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Central trial contact

Long Sun, PhD

Data sourced from clinicaltrials.gov

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