68Ga-FAP-RGD PET/CT : Dosimetry and Preliminary Clinical Translational Studies
Study Details
Study Description
Brief Summary
As an new dual targeting PET radiotracer, 68Ga-FAP-RGD is promising as an excellent imaging agent applicable to various cancers. In this study, we observed the safety, biodistribution and radiation dosimetry of 68Ga-FAP-RGD in patients with various types of cancer and compared them with the results of 68Ga-FAPI-02 or 18F-FDG imaging to evaluate the dosimetric characteristics and diagnostic efficacy of 68Ga-FAP-RGD.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1/Phase 2 |
Detailed Description
Fibroblast activation protein (FAP) is highly expressed in the stroma of a variety of human cancers and is therefore considered promising for guiding targeted therapy. The recent development of quinoline-based PET tracers that act as FAP inhibitors (FAPIs) demonstrated promising results preclinically and already in a few clinical cases. Integrin αvβ3 is restrictedly expressed on angiogenic blood vessels and tumour cells. It plays a key role in angiogenesis for tumour growth and metastasis. RGD peptide can specifically recognise the integrin αvβ3, which serves as targeted molecular for anti-angiogenesis strategies. 68Ga-FAP-RGD is a novel dual targeting tracers. The present study aimed to evaluate the biodistribution, pharmacokinetics, and dosimetry of 68Ga-FAP-RGD, and performed a head-to-head comparison with 68Ga-FAPI-02 or 18F-FDG PET/CT scans in patients with various cancers.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Part I: safety, tolerability, biodistribution and dosimetry PET imaging will begin at 30s (30s/bed), 15min (1min/bed), 30min (2 min/bed), 60min (2 min/bed) and 120min (2 min/bed) after injection |
Drug: 68Ga-FAP-RGD
The dose will be 4-7mCi given intravenously.
|
| Experimental: Part II: diagnostic efficacy Participants with various types of cancer will have PET imaging 50-100 minutes after injection of 68Ga-FAP-RGD and another agent (68Ga-FAPI-02 or 18F-FDG). |
Drug: 68Ga-FAP-RGD
68Ga-FAP-CHX, the dose will be 0.05 (mCi / kg) given intravenously at a single time prior to imaging. 68Ga-FAPI-02, the dose will be 1.8 (MBq /kg) given intravenously at a single time prior to imaging; 18F-FDG, the dose will be 3.7 (MBq / kg) given intravenously at a single time prior to imaging.
|
Outcome Measures
Primary Outcome Measures
- Human biodistribution [From right after tracer injection to 2-hours post-injection]
reported as relative uptake values per organ at 30s, 15min, 30min, 60min and 120 min per individual subject and as a mean over all subjects (Part I)
- Human dosimetry [From right after tracer injection to 2-hours post-injection]
radiation dose to individual organs and the equivalent dose for the whole body of each subject and as a mean over all subjects (Part I). Dosimetry will be calculated using the Hybrid-Dosimetry software.
- Standard uptake value (SUV) [Up to 2 weeks]
Determination of SUV for detected lesions and discernible organs of 68Ga-FAP-RGD and 68Ga-FAPI-02 or 18F-FDG
- Lesion numbers [Up to 2 weeks]
Determination of lesion numbers of 68Ga-FAP-RGD and 68Ga-FAPI-02 or 18F-FDG
- the sensitivity of 68Ga-FAP-RGD PET/CT [Up to 2 weeks]
compared with pathology or composite imaging, the sensitivity of 68Ga-FAP-RGD PET/CT was evaluated.
- the specificity of 68Ga-FAP-RGD PET/CT [Up to 2 weeks]
compared with pathology or composite imaging, the specificity of 68Ga-FAP-RGD PET/CT was evaluated.
- the accuracy of 68Ga-FAP-RGD PET/CT [Up to 2 weeks]
compared with pathology or composite imaging, the accuracy of 68Ga-FAP-RGD PET/CT was evaluated.
Secondary Outcome Measures
- Count of participants with treatment emergent adverse events [Up to 3 days]
The frequency and severity of treatment emergent adverse events following 68Ga-FAP-RGD injection will be descriptively reported as classified and graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Various solid tumors with available histopathological findings
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Signed informed consent
Exclusion Criteria:
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pregnant or lactational women
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who suffered from severe hepatic and renal insufficiency
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University | Fuzhou | Fujian | China |
Sponsors and Collaborators
- First Affiliated Hospital of Fujian Medical University
Investigators
- Study Chair: Weibing Miao, MD, The First Affiliated Hospital, Fujian Medical University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- FirstAHFujian-FAP-RGD