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

NCT ID: NCT05515783

Last Updated: 2023-09-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2024-05-01

Brief 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.

Conditions

Tumor

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

68Ga-FAP-RGD

Intervention Type: DRUG

The dose will be 4-7mCi given intravenously.

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).

Group Type: EXPERIMENTAL

68Ga-FAP-RGD

Intervention Type: DRUG

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.

Interventions

68Ga-FAP-RGD

The dose will be 4-7mCi given intravenously.

Intervention Type: 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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital of Fujian Medical University

OTHER

Sponsor Role: lead

Responsible Party

Weibing Miao, PhD

Director of Nuclear Medicine Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Weibing Miao, MD

Role: STUDY_CHAIR

The First Affiliated Hospital, Fujian Medical University

Locations

Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

Site Status: RECRUITING

Countries

China

Central Contacts

Weibing Miao, MD

Role: CONTACT

miaoweibing@126.com

86-0591-87981618

Jie Zang, MD,PhD

Role: CONTACT

15901495106@163.com

86-15901495106

Facility Contacts

Weibing Miao, MD

Role: primary

miaoweibing@126.com

059187981618

References

Chen Y, Zheng S, Zang J, Shao Z, Tu D, Liu Q, Chen X, Miao W, Zhang J. [68Ga]Ga-LNC1007 versus 2-[18F]FDG in the evaluation of patients with metastatic differentiated thyroid cancer: a head-to-head comparative study. Eur J Nucl Med Mol Imaging. 2025 Jan;52(2):683-692. doi: 10.1007/s00259-024-06930-4. Epub 2024 Oct 15.

Reference Type: DERIVED

PMID: 39404790 (View on PubMed)

Zang J, Lin R, Wen X, Wang C, Zhao T, Jakobsson V, Yang Y, Wu X, Guo Z, Chen X, Zhang J, Miao W. A Head-to-Head Comparison of 68Ga-LNC1007 and 2-18F-FDG/68Ga-FAPI-02 PET/CT in Patients With Various Cancers. Clin Nucl Med. 2023 Oct 1;48(10):861-868. doi: 10.1097/RLU.0000000000004820. Epub 2023 Sep 2.

Reference Type: DERIVED

PMID: 37682601 (View on PubMed)

Other Identifiers

FirstAHFujian-FAP-RGD

Identifier Type: -

Identifier Source: org_study_id