68Ga-FAPI-RGD PET/CT Imaging in the Lung Cancer Patients

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Enrolling; Early Phase 1

Conditions: Lung Neoplasms

Treatments: Drug: 18F-FDG; Drug: 68Ga-FAPI; Drug: 68Ga-FAPI-RGD; Drug: 68Ga-RGD

Study type: Interventional

Funder types: Other

Identifiers

NCT05543954

PUMCH-NM-FR

Details and patient eligibility

About

Based on the high expression of specific receptors on the surface of diseased tissues and neovascularization, noninvasive targeted molecular imaging can be used to visualize lesions in vitro by combining specific ligands labeled with short half-life isotopes. Lung cancer tissues express fibroblast activating protein FAP, and also have high expression of integrin αVβ3 receptor on the surface of blood vessels. In this study, a novel dual-target imaging agent 68Ga-FAPI-RGD was used for PET/CT imaging of lung cancer.

Full description

Conventional 18F-FDG PET/CT has important diagnostic value in cell metabolism level, early metastasis, judging malignant potential and prognosis of tumors. It has been routinely used for staging and restaging of most tumors, but there are still some tumors with low uptake of 18F-FDG PET/CT. Moreover, 18F-FDG cannot distinguish between tumors and inflammatory diseases, such as tuberculosis and granuloma. Receptor imaging with a single target also has some limitations in clinical application. For example, not all diseased cells express a large amount of single receptor on the surface, which greatly affects the judgment of the nature of the lesion. The dual-target molecular imaging based on FAP expressed in the lesion site and integrin αvβ3 receptor highly expressed on the surface of the lesion neovascularization will overcome the above limitations and make full use of the advantages of the dual-target molecular imaging, which will greatly assist the diagnosis of malignant tumors such as lung cancer. In this study, a novel dual-target imaging agent 68Ga-FAPI-RGD was used for PET/CT imaging of lung cancer, compared with conventional 18F-FDG, or single target imaging agent 68Ga-RGD or 68Ga-FAPI PET/CT imaging.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with confirmed or suspected lung cancer;
• 68Ga-FAPI-RGD and 18F-FDG(or 68Ga-FAPI or 68Ga-RGD) PET/CT within 2 week;
• signed written consent.

Exclusion criteria

• pregnancy;
• breastfeeding;
• any medical condition that in the opinion of the investigator may significantly interfere with study compliance.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

68Ga-FAPI-RGD and 18F-FDG PET/ CT scan

Experimental group

Description:

Within 2 week, each patient underwent PET/CT scan after intravenous administration of 68Ga-FAPI-RGD and 18F-FDG, respectively.

Treatment:

Drug: 68Ga-FAPI-RGD

Drug: 18F-FDG

68Ga-FAPI-RGD and 68Ga-FAPI PET/ CT scan

Experimental group

Description:

Within 2 week, each patient underwent PET/CT scan after intravenous administration of 68Ga-FAPI-RGD and 68Ga-FAPI, respectively.

Treatment:

Drug: 68Ga-FAPI-RGD

Drug: 68Ga-FAPI

68Ga-FAPI-RGD and 68Ga-RGD PET/ CT scan

Experimental group

Description:

Within 2 week, each patient underwent PET/CT scan after intravenous administration of 68Ga-FAPI-RGD and 68Ga-RGD, respectively.

Treatment:

Drug: 68Ga-RGD

Drug: 68Ga-FAPI-RGD