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

NCT ID: NCT05810324

Condition: Cancer

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: 18F-FAPI
Description: Each patient receive a single intravenous injection of 18F-FAPI, and undergo PET/CT scan within specified time.
Arm group label: 18F-FAPI

Other name: FAPI

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.

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: No

Locations:

Facility:
Name: China-Japan Union Hospital

Address:
City: Chang chun
Zip: 130031
Country: China

Status: Recruiting

Contact:
Last name: Jun Wei

Phone: +8684995117
Email: Weijunsy1949@163.com

Start date: July 1, 2022

Completion date: January 1, 2025

Lead sponsor:
Agency: Jilin University
Agency class: Other

Source: Jilin University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05810324

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