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NCT05810324 Clinical Trial

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

Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05810324
Other study ID # ChinaJapanUHJLU
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 1, 2022
Est. completion date January 1, 2025

Study information
Verified date March 2023
Source Jilin University
Contact Shi Gao
Phone +86-0431-84995467
Email Gaoshi@jlu.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 500
Est. completion date January 1, 2025
Est. primary completion date July 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• 18F-FAPI
Each patient receive a single intravenous injection of 18F-FAPI, and undergo PET/CT scan within specified time.

Locations
Country Name City State
China China-Japan Union Hospital Chang chun Jilin

Sponsors (1)
Lead Sponsor Collaborator
Jilin University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Diagnostic accuracy The sensitivity, specificity and accuracy of 18F-FAPI PET/CT were calculated. 1 year
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