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

Early Phase 1
Recruiting
Conditions
Lung Neoplasms
Interventions
Drug: 68Ga-FAPI-RGD
Drug: 68Ga-RGD
Registration Number
NCT05543954
Lead Sponsor
Peking Union Medical College Hospital
Brief 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.

Detailed 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 & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
60
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
68Ga-FAPI-RGD and 18F-FDG PET/ CT scan68Ga-FAPI-RGDWithin 2 week, each patient underwent PET/CT scan after intravenous administration of 68Ga-FAPI-RGD and 18F-FDG, respectively.
68Ga-FAPI-RGD and 68Ga-FAPI PET/ CT scan68Ga-FAPI-RGDWithin 2 week, each patient underwent PET/CT scan after intravenous administration of 68Ga-FAPI-RGD and 68Ga-FAPI, respectively.
68Ga-FAPI-RGD and 68Ga-RGD PET/ CT scan68Ga-FAPI-RGDWithin 2 week, each patient underwent PET/CT scan after intravenous administration of 68Ga-FAPI-RGD and 68Ga-RGD, respectively.
68Ga-FAPI-RGD and 68Ga-RGD PET/ CT scan68Ga-RGDWithin 2 week, each patient underwent PET/CT scan after intravenous administration of 68Ga-FAPI-RGD and 68Ga-RGD, respectively.
68Ga-FAPI-RGD and 68Ga-FAPI PET/ CT scan68Ga-FAPIWithin 2 week, each patient underwent PET/CT scan after intravenous administration of 68Ga-FAPI-RGD and 68Ga-FAPI, respectively.
68Ga-FAPI-RGD and 18F-FDG PET/ CT scan18F-FDGWithin 2 week, each patient underwent PET/CT scan after intravenous administration of 68Ga-FAPI-RGD and 18F-FDG, respectively.
Primary Outcome Measures
NameTimeMethod
Diagnostic performance1through study completion, an average of 1 year

comparing the SUV and number of lung cancer or metastasis detected by 68Ga-FAPI-RGD and 18F-FDG PET/CT

Diagnostic performance2through study completion, an average of 1 year

comparing the SUV and number of lung cancer or metastasis detected by 68Ga-FAPI-RGD and 68Ga-FAPI PET/CT

Diagnostic performance3through study completion, an average of 1 year

comparing the SUV and number of lung cancer or metastasis detected by 68Ga-FAPI-RGD and 68Ga-RGD PET/CT

Secondary Outcome Measures
NameTimeMethod
The dosimetry of 68Ga-FAPI-RGDthrough study completion, an average of 1 year

Measure the distribution of 68Ga-FAPI-RGD in 6-8 lung cancer patients by 3-hour dynamic PET/CT acquisition by dosimetry software

68Ga-FAPI-RGD uptake at different time pointsthrough study completion, an average of 1 year

The SUV uptake of tumors and metastases in patients with lung cancer was measured at 1, 2, and 3 hours.

Trial Locations

Locations (1)

Peking Union Medical College Hospital

🇨🇳

Beijing, China

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