Lung Neoplasms
Conditions
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.
Interventions
DRUG68Ga-FAPI-RGD
Intravenous injection of 68Ga-FAPI-RGD with a dosage of approximately 1.8-2.2 MBq (0.05-0.06 mCi)/kg.
DRUG18F-FDG
Intravenous injection of 18F-FDG with a dosage of approximately 3.7-5.55 MBq (0.1-0.15 mCi)/kg.
DRUG68Ga-FAPI
Intravenous injection of 68Ga-FAPI with a dosage of approximately 1.8-2.2 MBq (0.05-0.06 mCi)/kg.
DRUG68Ga-RGD
Intravenous injection of 68Ga-RGD with a dosage of approximately 1.8-2.2 MBq (0.05-0.06 mCi)/kg.
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic performance1 | through 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 performance2 | through 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 performance3 | through 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
| Measure | Time frame | Description |
|---|---|---|
| The dosimetry of 68Ga-FAPI-RGD | through 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 points | through 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. |
Countries
China
Contacts
Primary ContactZhaohui Zhu, MD,PHD
Backup ContactRongxi Wang
Outcome results
None listed