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

Lung Neoplasms Clinical Trial

Official title:

A Pilot Study of 68Ga-FAPI-RGD PET/CT Imaging in the Lung Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05543954
• Other study ID #: PUMCH-NM-FR
• Status: Recruiting
• Phase: Early Phase 1
• Start date: September 3, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: September 2022
• Source: Peking Union Medical College Hospital
• Contact: Zhaohui Zhu, MD,PHD
• Phone: 86+13611093752
• Email: 13611093752[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Neoplasms

Intervention

Drug:
• 68Ga-FAPI-RGD
Intravenous injection of 68Ga-FAPI-RGD with a dosage of approximately 1.8-2.2 MBq (0.05-0.06 mCi)/kg.
• 18F-FDG
Intravenous injection of 18F-FDG with a dosage of approximately 3.7-5.55 MBq (0.1-0.15 mCi)/kg.
• 68Ga-FAPI
Intravenous injection of 68Ga-FAPI with a dosage of approximately 1.8-2.2 MBq (0.05-0.06 mCi)/kg.
• 68Ga-RGD
Intravenous injection of 68Ga-RGD with a dosage of approximately 1.8-2.2 MBq (0.05-0.06 mCi)/kg.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic performance1	comparing the SUV and number of lung cancer or metastasis detected by 68Ga-FAPI-RGD and 18F-FDG PET/CT	through study completion, an average of 1 year
Primary	Diagnostic performance2	comparing the SUV and number of lung cancer or metastasis detected by 68Ga-FAPI-RGD and 68Ga-FAPI PET/CT	through study completion, an average of 1 year
Primary	Diagnostic performance3	comparing the SUV and number of lung cancer or metastasis detected by 68Ga-FAPI-RGD and 68Ga-RGD PET/CT	through study completion, an average of 1 year
Secondary	The dosimetry of 68Ga-FAPI-RGD	Measure the distribution of 68Ga-FAPI-RGD in 6-8 lung cancer patients by 3-hour dynamic PET/CT acquisition by dosimetry software	through study completion, an average of 1 year
Secondary	68Ga-FAPI-RGD uptake at different time points	The SUV uptake of tumors and metastases in patients with lung cancer was measured at 1, 2, and 3 hours.	through study completion, an average of 1 year