Positron-Emission Tomography, Tumor, Solid
Conditions
Keywords
Tumor, Solid, Positron-Emission Tomography, diagnosis
Brief summary
To evaluate the potential usefulness of 68Ga-FAP-2286 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
Subjects with various types of cancer underwent contemporaneous 68Ga-FAP-2286 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-FAP-2286 PET/CT were recorded by visual interpretation. The sensitivity, specificity, and accuracy of 68Ga-FAP-2286, 18F-FDG PET/CT were calculated and compared to evaluate the diagnostic accuracy.
Interventions
DIAGNOSTIC_TEST18F-FDG
Each subject receives a single intravenous injection of 18F-FDG and 68Ga-FAP-2286, and undergo PET/CT imaging within the specified time. A part of participants will also 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 No maximum
Healthy volunteers
No
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-FAP-2286 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 accuracy | 90 days | The sensitivity, specificity, and accuracy of 18F-FDG and 68Ga-FAP-2286 PET/CT were calculated and compared to evaluate the diagnostic efficacy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Standardized uptake value (SUV) | 30 days | Standardized uptake value (SUV) of 18F-FDG and 68Ga-FAP-2286 PET/CT for each target lesion of subject or suspected primary tumor or/and metastasis. |
| Number of lesions | 90 days | The numbers of positive primary and metastatic lesions of 18F-FDG and 68Ga-FAP-2286 PET/CT were recorded by visual interpretation. |
Countries
China
Outcome results
None listed