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

68Ga-FAP-RGD PET/CT : Dosimetry and Preliminary Clinical Translational Studies in Cancer Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Tumor
• Intervention / Treatment: Drug: 68Ga-FAP-RGD; Drug: 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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Jie Zang, MD,PhD; Phone Number: 86-15901495106; Email: 15901495106@163.com
• Study Contact Backup: Name: weibing miao, MD; Phone Number: 86-0591-87981618; Email: miaoweibing@126.com

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China
      • Recruiting
      • Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
      • Contact: Weibing Miao, MD; Phone Number: 059187981618; Email: miaoweibing@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part I: safety, tolerability, biodistribution and dosimetry; PET imaging will begin at 30s (30s/bed), 15min (1min/bed), 30min (2 min/bed), 60min (2 min/bed) and 120min (2 min/bed) after injection	Drug: 68Ga-FAP-RGD; The dose will be 4-7mCi given intravenously.; Drug: 68Ga-FAP-RGD; 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.
Experimental: Part II: diagnostic efficacy; Participants with various types of cancer will have PET imaging 50-100 minutes after injection of 68Ga-FAP-RGD and another agent (68Ga-FAPI-02 or 18F-FDG).	Drug: 68Ga-FAP-RGD; The dose will be 4-7mCi given intravenously.; Drug: 68Ga-FAP-RGD; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Human biodistribution	reported as relative uptake values per organ at 30s, 15min, 30min, 60min and 120 min per individual subject and as a mean over all subjects (Part I)	From right after tracer injection to 2-hours post-injection
Human dosimetry	radiation dose to individual organs and the equivalent dose for the whole body of each subject and as a mean over all subjects (Part I). Dosimetry will be calculated using the Hybrid-Dosimetry software.	From right after tracer injection to 2-hours post-injection
Standard uptake value (SUV)	Determination of SUV for detected lesions and discernible organs of 68Ga-FAP-RGD and 68Ga-FAPI-02 or 18F-FDG	Up to 2 weeks
Lesion numbers	Determination of lesion numbers of 68Ga-FAP-RGD and 68Ga-FAPI-02 or 18F-FDG	Up to 2 weeks
the sensitivity of 68Ga-FAP-RGD PET/CT	compared with pathology or composite imaging, the sensitivity of 68Ga-FAP-RGD PET/CT was evaluated.	Up to 2 weeks
the specificity of 68Ga-FAP-RGD PET/CT	compared with pathology or composite imaging, the specificity of 68Ga-FAP-RGD PET/CT was evaluated.	Up to 2 weeks
the accuracy of 68Ga-FAP-RGD PET/CT	compared with pathology or composite imaging, the accuracy of 68Ga-FAP-RGD PET/CT was evaluated.	Up to 2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Count of participants with treatment emergent adverse events	The frequency and severity of treatment emergent adverse events following 68Ga-FAP-RGD injection will be descriptively reported as classified and graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0	Up to 3 days

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Fujian Medical University
• Investigators: Study Chair: Weibing Miao, MD, the First Affiliated Hospital, Fujian Medical University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: August 23, 2022
• First Submitted That Met QC Criteria: August 23, 2022
• First Posted (Actual): August 25, 2022

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 16, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: FirstAHFujian-FAP-RGD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No