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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

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