Positron-Emission Tomography, Tumor, Solid
Conditions
Keywords
Tumor, Solid, Positron-Emission Tomography, diagnosis
Brief summary
As a new dual receptor (integrin αvβ3 and FAP) targeting PET radiotracer, 68Ga-FAPI-RGD is promising as an excellent imaging agent applicable to various cancers. In this research, we investigate the safety, biodistribution and radiation dosimetry of 68Ga-FAPI-RGD in healthy volunteers. Moreover, we evaluate the potential usefulness of 68Ga-FAPI-RGD positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various types of cancer, and compared with 18F-FDG PET/CT.
Detailed description
As a new dual receptor (integrin αvβ3 and FAP) targeting PET radiotracer, 68Ga-FAPI-RGD is promising as an excellent imaging agent applicable to various cancers. In this research, we investigate the safety, biodistribution and radiation dosimetry of 68Ga-FAPI-RGD in healthy volunteers. Moreover, Subjects with various types of cancer underwent contemporaneous 68Ga-FAPI-RGD and 18F-FDG PET/CT either for an initial assessment or for recurrence detection. Tumor uptake was quantified by the maximum standard uptake value (SUVmax). The numbers of positive tumor lesions of 18F-FDG and 68Ga-FAPI-RGD PET/CT were recorded by visual interpretation. The diagnostic accuracy of 68Ga-FAPI-RGD were calculated and compared to 18F-FDG PET/CT.
Interventions
DIAGNOSTIC_TEST18F-FDG PET/CT, 68Ga-FAPI-RGD PET/CT
Each subject receives a single intravenous injection of 18F-FDG and 68Ga-FAP-RGD, and undergo PET/CT imaging within the specified time. A part of participants will undergo additional 68Ga-FAPI-46 PET/CT for comparison.
Sponsors
The First Affiliated Hospital of Xiamen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
* adult patients (aged 18 years or order); * patients with suspected or newly diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report); * patients who had scheduled both 18F-FDG and 68Ga-FAPI-RGD PET/CT scans; * patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.
Exclusion criteria
* patients with non-malignant lesions; * patients with pregnancy; * the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic efficacy | 30 days | The sensitivity, specificity, and accuracy of 18F-FDG and 68Ga-FAPI-RGD PET/CT were calculated and compared to evaluate the diagnostic accuracy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of lesions | 30 days | The numbers of positive primary and metastatic lesions of 18F-FDG and 68Ga-FAPI-RGD PET/CT were recorded by visual interpretation. |
| SUV | 7 days | Standardized uptake value (SUV) of 18F-FDG and 68Ga-FAPI-RGD PET/CT for each target lesion of subject or suspected primary tumor or/and metastasis. |
Countries
China
Outcome results
None listed