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Clinical Trials/NCT05810324
NCT05810324
Recruiting
Not Applicable

The Performance of 18F-FAPI PET/CT in Patients With Various Types of Cancer

Jilin University1 site in 1 country500 target enrollmentJuly 1, 2022
ConditionsCancer
Interventions18F-FAPI

Overview

Phase
Not Applicable
Intervention
18F-FAPI
Conditions
Cancer
Sponsor
Jilin University
Enrollment
500
Locations
1
Primary Endpoint
Diagnostic accuracy
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

To evaluate the potential usefulness of 18F-FAPI positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various types of cancer.

Detailed Description

Subjects with various types of cancer underwent 18F-FAPI PET/CT either for an initial assessment or for recurrence detection. Tumor uptake was quantified by the maximum standard uptake value (SUVmax). Using histopathology and follow-up as gold standard, the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 18F-FAPI PET/CT were calculated.

Registry
clinicaltrials.gov
Start Date
July 1, 2022
End Date
January 1, 2025
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Jilin University
Responsible Party
Principal Investigator
Principal Investigator

Ji Bin

Doctor

Jilin University

Eligibility Criteria

Inclusion Criteria

  • patients with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report);
  • patients who had scheduled 18F-FAPI PET/CT scan; (iv)
  • 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.

Arms & Interventions

18F-FAPI

Experimental: Experimental: 18F-FAPI Each subject receive a single intravenous injection of 18F-FAPI, and undergo PET/CT imaging within the specificed time.

Intervention: 18F-FAPI

Outcomes

Primary Outcomes

Diagnostic accuracy

Time Frame: 1 year

The sensitivity, specificity and accuracy of 18F-FAPI PET/CT were calculated.

Study Sites (1)

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