What is 68Ga-DOTA-NI-FAPI04 studying for cancer?

68Ga-DOTA-NI-FAPI04 is being studied to see how well it can detect tumors in patients with various types of cancer. Researchers aim to compare its imaging results with other PET/CT tracers to improve cancer diagnosis. The study is sponsored by the First Affiliated Hospital of Fujian Medical University.

Who may be eligible for this tumor clinical trial?

Adults aged 18 to 80 with solid tumors confirmed by pathology may be eligible. Both men and women can join, except pregnant or breastfeeding women and those with severe liver or kidney problems. Please review eligibility criteria for more details.

Is there any cost to participate in this tumor clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. However, personal travel and other expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Early Phase 1

Age: 18Years - 80Years

All Genders

ID06455761

68Ga-DOTA-NI-FAPI04 PETCT Imaging Study in Patients With Various Types of Cancer

Led by First Affiliated Hospital of Fujian Medical University · Updated on 2024-06-12

Participants Needed

Research Sites

39 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the diagnostic performance of a new radiotracer called 68Ga-DOTA-NI-FAPI04 in patients with various types of cancer. This tracer targets fibroblast activation protein FAP, which is highly expressed in tumors but limited in normal tissues. The study compares 68Ga-DOTA-NI-FAPI04 PETCT imaging results with those from other PETCT tracers like 68Ga-FAPI and 18F-FDG to see how well it detects tumors. Participants receive an intravenous injection of either 68Ga-DOTA-NI-FAPI04 at a dose of 111-148 MBq 3-4 mCi or a dose of 68Ga-FAPI or 18F-FDG 111-148 MBq for 68Ga-FAPI or 3.7 MBqkg for 18F-FDG. These tracer doses are used to detect tumors through PETCT scans. The trial is randomized and open-label, meaning participants are assigned to one of these groups without blinding. During the study, participants undergo PETCT imaging to assess tumor detection and uptake values. The primary outcome measure is the diagnostic value of the imaging over about three months. Secondary outcomes include measuring the standardized uptake value SUV of tumors. The study runs from April 2024 to December 2025, with safety and diagnostic performance monitored throughout.

CONDITIONS

Brief Title

68Ga-DOTA-NI-FAPI04 PET/CT in Patients With Various Types of Cancer

Who Can Participate

Age: 18Years - 80Years

All Genders

Eligibility Criteria

You may qualify if you...

Adults aged 18 to 80 years
Diagnosed with various solid tumors confirmed by histopathology
Signed informed consent to participate in the study

You will not qualify if you...

Pregnant or breastfeeding women
Severe liver (hepatic) insufficiency
Severe kidney (renal) insufficiency

Research Team

Weibing Miao, MD

Guochang Wang, MD

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