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68Ga-FAP-CHX PET/CT : Dosimetry and Preliminary Clinical Translational Studies

NCT05506566 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-09-21

No results posted yet for this study

Summary

As an emerging molecule targeting FAP, 68Ga-FAP-CHX is promising as an excellent imaging agent applicable to various cancers. In this study, we observed the safety, biodistribution and radiation dosimetry of 68Ga-FAP-CHX in patients with various types of cancer and compared them with the results of 68Ga-FAPI-04 or 18F-FDG imaging to evaluate the dosimetric characteristics and diagnostic efficacy of 68Ga-FAP-CHX.

Conditions

  • Tumor
  • Positron-Emission Tomography

Interventions

DRUG

68Ga-FAP-CHX

The dose will be 0.05 (mCi / kg) +/- 10% given intravenously at a single time prior to imaging

DRUG

68Ga-FAP-CHX

68Ga-FAP-CHX, the dose will be 0.05 (mCi / kg) +/- 10% given intravenously at a single time prior to imaging； 68Ga-FAPI-04, the dose will be 1.8 (MBq / kg) +/- 10% given intravenously at a single time prior to imaging； 18F-FDG, the dose will be 3.7 (MBq / kg) +/- 10% given intravenously at a single time prior to imaging；

Sponsors & Collaborators

  • First Affiliated Hospital of Fujian Medical University

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-01
Primary Completion
2025-05-01
Completion
2025-05-01

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 NCT05506566 on ClinicalTrials.gov