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HIPAA Compliant
ISO 27001 Certified

Actively Recruiting

Early Phase 1
Age: 18Years - 90Years
All Genders
ID04499365

Evaluating 68Ga-DOTANOTA-FAPI-04 PETCT for Diagnosing Primary and Metastatic Cancer in Adults

Led by First Affiliated Hospital of Fujian Medical University · Updated on 2026-07-21

500

Participants Needed

1

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the usefulness of 68Ga-DOTANOTA-FAPI-04 positron emission tomographycomputed tomography PETCT for diagnosing primary and metastatic lesions across various cancer types. This early phase 1 interventional study aims to assess how well this imaging method detects tumors in patients with suspected, newly diagnosed, or previously treated malignant tumors. Participants receive a single intravenous injection of the 68Ga-DOTANOTA-FAPI-04 drug followed by a PETCT scan within a specified time frame. The study focuses on quantifying tumor uptake using the maximum standard uptake value SUVmax and calculates diagnostic measures such as sensitivity, specificity, positive and negative predictive values, and accuracy. During the study, participants undergo the PETCT scan after injection and provide informed consent. Researchers measure the standardized uptake value within 30 days and evaluate diagnostic efficacy. The study monitors outcomes related to tumor detection, and participation lasts around the time needed for these assessments, with no ongoing treatment or long-term follow-up specified.

CONDITIONS

Brief Title

68Ga-FAPI PET/CT in Patients With Various Types of Cancer

Research Team

W

Weibing Miao, MD

S

Shan Zheng, MD

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