Clinical trial Recruiting at 1 site Early Phase 1 Interventional Ages 18 to 80

First use of 68Ga-NI-FAPI PET/CT for cancer diagnosis

Official title: 68Ga-NI-FAPI PET/CT: First-in-human Study in Patients With Various Cancers

Run by First Affiliated Hospital of Fujian Medical University · NCT06688305 · Data updated 2026-11-12

This study is testing a new imaging agent called 68Ga-NI-FAPI to see if it can help doctors better spot different types of cancer using PET/CT scans.

More Malignant Neoplasm trials

Quick facts

PhaseEarly Phase 1
Study typeInterventional
Ages18 Years to 80 Years
SexAll
Enrollment40 (estimated)
SponsorFirst Affiliated Hospital of Fujian Medical University
Academic / other
Drugs / interventionsradiation
Locations1 site (Fuzhou, Fujian)
StatusRecruiting
StartedAugust 1, 2024
Main results expectedJuly 31, 2025
Study endsDecember 31, 2025
Registry record updatedNovember 14, 2024
Trial IDNCT06688305 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include patients with various solid tumors who have confirmed histopathological findings.

Probably not a fit

Patients who are pregnant, lactating, or have severe hepatic and renal insufficiency may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and diagnostic effectiveness of a new radiotracer, 68Ga-NI-FAPI, in patients with various types of cancer. The radiotracer targets carcinoma-associated fibroblasts, which are commonly overexpressed in malignant tumors. The study aims to assess how well this new agent can visualize tumors using PET/CT imaging, along with its biodistribution and radiation dosimetry. By focusing on a specific marker found in over 90% of epithelial malignant tumors, this approach could enhance cancer diagnosis and management.

Why it matters

Potential benefit: If successful, this could lead to improved diagnostic accuracy for various cancers, allowing for better treatment planning.

How similar studies have gone: Previous studies using other FAP-targeting tracers have shown promising results in cancer diagnostics, suggesting potential success for this novel approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Various solid tumors with available histopathological findings
* Signed informed consent

Exclusion Criteria:

* pregnant or lactational women
* who suffered from severe hepatic and renal insufficiency

Where it's running

  • Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
    Fuzhou, Fujian, China
    Recruiting

Study contacts

  • Principal investigator: Weibing Miao, MD — First Affiliated Hospital of Fujian Medical University
  • Study coordinator: Weibing Miao, MD
  • Email: miaoweibing@126.com
  • Phone: +86-0591-87981618

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.