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

NCT06688305 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-11-14

No results posted yet for this study

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.

Conditions

  • Malignant Neoplasm

Interventions

DRUG

68Ga-NI-FAPI

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

Sponsors & Collaborators

  • First Affiliated Hospital of Fujian Medical University

    lead OTHER

Principal Investigators

  • Weibing Miao, MD · First Affiliated Hospital of Fujian Medical University

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-01
Primary Completion
2025-07-31
Completion
2025-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06688305 on ClinicalTrials.gov