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Trial Title:
68Ga-FAPI-RGD PET/CT Imaging in the Lung Cancer Patients
NCT ID:
NCT05543954
Condition:
Lung Neoplasms
Conditions: Official terms:
Lung Neoplasms
Fluorodeoxyglucose F18
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
68Ga-FAPI-RGD
Description:
Intravenous injection of 68Ga-FAPI-RGD with a dosage of approximately 1.8-2.2 MBq
(0.05-0.06 mCi)/kg.
Arm group label:
68Ga-FAPI-RGD and 18F-FDG PET/ CT scan
Arm group label:
68Ga-FAPI-RGD and 68Ga-FAPI PET/ CT scan
Arm group label:
68Ga-FAPI-RGD and 68Ga-RGD PET/ CT scan
Other name:
68Ga-FAPI-RGD injection
Intervention type:
Drug
Intervention name:
18F-FDG
Description:
Intravenous injection of 18F-FDG with a dosage of approximately 3.7-5.55 MBq (0.1-0.15
mCi)/kg.
Arm group label:
68Ga-FAPI-RGD and 18F-FDG PET/ CT scan
Other name:
18F-FDG injection
Intervention type:
Drug
Intervention name:
68Ga-FAPI
Description:
Intravenous injection of 68Ga-FAPI with a dosage of approximately 1.8-2.2 MBq (0.05-0.06
mCi)/kg.
Arm group label:
68Ga-FAPI-RGD and 68Ga-FAPI PET/ CT scan
Other name:
68Ga-FAPI injection
Intervention type:
Drug
Intervention name:
68Ga-RGD
Description:
Intravenous injection of 68Ga-RGD with a dosage of approximately 1.8-2.2 MBq (0.05-0.06
mCi)/kg.
Arm group label:
68Ga-FAPI-RGD and 68Ga-RGD PET/ CT scan
Other name:
68Ga-RGD injection
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking Union Medical College Hospital
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhaohui Zhu, MD,PHD
Phone:
86+13611093752
Email:
13611093752@163.com
Start date:
September 3, 2022
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Peking Union Medical College Hospital
Agency class:
Other
Source:
Peking Union Medical College Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05543954
