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Trial Title:
68Ga-FAP-CHX PET/CT : Dosimetry and Preliminary Clinical Translational Studies
NCT ID:
NCT05506566
Condition:
Tumor
Positron-Emission Tomography
Conditions: Official terms:
Fluorodeoxyglucose F18
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
68Ga-FAP-CHX
Description:
The dose will be 0.05 (mCi / kg) +/- 10% given intravenously at a single time prior to
imaging
Arm group label:
Part I: safety, tolerability, biodistribution and dosimetry
Intervention type:
Drug
Intervention name:
68Ga-FAP-CHX
Description:
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;
Arm group label:
Part II: diagnostic efficacy
Other name:
68Ga-FAPI-04
Other name:
18F-FDG
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.
Detailed description:
Fibroblast activation protein (FAP) is highly expressed in the stroma of a variety of
human cancers and is therefore considered promising for guiding targeted therapy. The
recent development of quinoline-based PET tracers that act as FAP inhibitors (FAPIs)
demonstrated promising results preclinically and already in a few clinical cases.
68Ga-FAP-CHX is a novel FAP-targeted tracers. The present study aimed to evaluate the
biodistribution, pharmacokinetics, and dosimetry of 68Ga-FAP-CHX, and performed a
head-to-head comparison with 68Ga-FAPI-04 or 18F-FDG PET/CT scans in patients with
various cancers.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 18 years < Age < 75 years
- Various solid tumors with available histopathological findings, and have not been
treated surgically.
- Signed informed consent.
Exclusion Criteria:
- patients with pregnancy
- the inability or unwillingness of the research participant, parent or legal
representative to provide written informed consent.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
Address:
City:
Fuzhou
Zip:
350005
Country:
China
Status:
Recruiting
Contact:
Last name:
Weibing Miao, MD
Phone:
059187981618
Email:
miaoweibing@126.com
Contact backup:
Last name:
Jie Zang, MD
Phone:
15901495106
Email:
15901495106@163.com
Start date:
May 1, 2022
Completion date:
May 1, 2025
Lead sponsor:
Agency:
First Affiliated Hospital of Fujian Medical University
Agency class:
Other
Source:
First Affiliated Hospital of Fujian Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05506566