RecruitingEarly Phase 1NCT06688305

68Ga-NI-FAPI PET/CT: First-in-human Study

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


Sponsor

First Affiliated Hospital of Fujian Medical University

Enrollment

40 participants

Start Date

Aug 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

68Ga-NI-FAPI is a novel radiotracer incorporating a hypoxia sensitive nitroimidazole (NI)-moiety and a FAP-targeting. In this study, we observed the safety, biodistribution, radiation dosimetry and diagnostic value of 68Ga-NI-FAPI PET/CT in patients with different types of cancer.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria2

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

Exclusion Criteria2

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

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Interventions

DRUG68Ga-NI-FAPI

Intravenous injection of one dosage of 111-148 MBq (3-4 mCi) 68Ga-NI-FAPI.


Locations(1)

Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

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NCT06688305


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