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Trial Title:
68Ga-FAP-RGD PET/CT : Dosimetry and Preliminary Clinical Translational Studies
NCT ID:
NCT05515783
Condition:
Tumor
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
68Ga-FAP-RGD
Description:
The dose will be 4-7mCi given intravenously.
Arm group label:
Part I: safety, tolerability, biodistribution and dosimetry
Intervention type:
Drug
Intervention name:
68Ga-FAP-RGD
Description:
68Ga-FAP-CHX, the dose will be 0.05 (mCi / kg) given intravenously at a single time prior
to imaging. 68Ga-FAPI-02, the dose will be 1.8 (MBq /kg) given intravenously at a single
time prior to imaging; 18F-FDG, the dose will be 3.7 (MBq / kg) given intravenously at a
single time prior to imaging.
Arm group label:
Part II: diagnostic efficacy
Summary:
As an new dual targeting PET radiotracer, 68Ga-FAP-RGD 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-RGD in patients with various types of
cancer and compared them with the results of 68Ga-FAPI-02 or 18F-FDG imaging to evaluate
the dosimetric characteristics and diagnostic efficacy of 68Ga-FAP-RGD.
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.
Integrin αvβ3 is restrictedly expressed on angiogenic blood vessels and tumour cells. It
plays a key role in angiogenesis for tumour growth and metastasis. RGD peptide can
specifically recognise the integrin αvβ3, which serves as targeted molecular for
anti-angiogenesis strategies. 68Ga-FAP-RGD is a novel dual targeting tracers. The present
study aimed to evaluate the biodistribution, pharmacokinetics, and dosimetry of
68Ga-FAP-RGD, and performed a head-to-head comparison with 68Ga-FAPI-02 or 18F-FDG PET/CT
scans in patients with various cancers.
Criteria for eligibility:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
Address:
City:
Fuzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Weibing Miao, MD
Phone:
059187981618
Email:
miaoweibing@126.com
Start date:
May 1, 2022
Completion date:
May 1, 2024
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/NCT05515783