68Ga-FAPI-LM3 PET/CT Imaging in Patients With FAP/SSTR2 Positive Disease and Compared With 18F-FDG
Study Details
Study Description
Brief Summary
As a new dual receptor (SSTR2 and FAP) targeting PET radiotracer, 68Ga-FAPI-LM3 is promising as an excellent imaging agent applicable to SSTR2 positive diseases. In this research, we investigate the safety, biodistribution and radiation dosimetry of 68Ga-FAPI-LM3 in healthy volunteers. Moreover, we evaluate the potential usefulness of 68Ga-FAPI-LM3 positron emission tomography/computed tomography (PET/CT) for the diagnosis of lesions in SSTR2 positive diseases, and compared with 18F-FDG PET/CT.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
As a new dual receptor (SSTR2 and FAP) targeting PET radiotracer, 68Ga-FAPI-LM3 is promising as an excellent imaging agent applicable to SSTR2 positive diseases In this research, we investigate the safety, biodistribution and radiation dosimetry of 68Ga-FAPI-LM3 in healthy volunteers. Moreover, subjects with SSTR2 positive diseases underwent contemporaneous 68Ga-FAPI-LM3 and 18F-FDG PET/CT for diseases assessment. Lesions uptakes were quantified by the maximum standard uptake value (SUVmax). The numbers of positive lesions of 18F-FDG and 68Ga-FAPI-LM3 PET/CT were recorded by visual interpretation. The diagnostic accuracy of 68Ga-FAPI-LM3 were calculated and compared to 18F-FDG PET/CT.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 68Ga-FAPI-LM3 Each subject receives a single intravenous injection of 18F-FDG and 68Ga-FAPI-LM3, and undergo PET/CT imaging within the specified time. |
Diagnostic Test: 18F-FDG PET/CT, 68Ga-FAPI-LM3 PET/CT
Each subject receives a single intravenous injection of 18F-FDG and 68Ga-FAP-LM3, and undergo PET/CT imaging within the specified time. A part of participants will undergo additional 68Ga-FAPI-46 PET/CT for comparison.
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Outcome Measures
Primary Outcome Measures
- Diagnostic efficacy [30 days]
The sensitivity, specificity, and accuracy of 18F-FDG and 68Ga-FAPI-LM3 PET/CT were calculated and compared to evaluate the diagnostic accuracy
Secondary Outcome Measures
- SUV [2 days]
Standardized uptake value (SUV) of 18F-FDG and 68Ga-FAPI-LM3 PET/CT for each positive lesion of subject.
- Number of lesions [2 days]
The numbers of positive lesions of 18F-FDG and 68Ga-FAPI-LM3 PET/CT were recorded by visual interpretation.
Eligibility Criteria
Criteria
Inclusion Criteria:
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(i) adult patients (aged 18 years or order);
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(ii) patients with suspected or newly diagnosed or previously malignant disease, with either FAP or SSTR2 positive expression (supporting evidence may include MRI, CT, and pathology report etc);
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(iii) patients who had scheduled both 18F-FDG and 68Ga-FAPI-LM3 PET/CT scans;
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(iv) 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:
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(i) patients with non-malignant disease;
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(ii) patients with pregnancy;
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(iii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The First Affiliated Hospital of Xiamen University | Xiamen | Fujian | China | 0086-361000 |
Sponsors and Collaborators
- The First Affiliated Hospital of Xiamen University
Investigators
- Study Director: Long Sun, PhD, The First Affiliated Hospital of Xiamen University, Fujian, China
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- XMFHIIT-2022SL070