68Ga-FAP-RGD PET/CT : Dosimetry and Preliminary Clinical Translational Studies

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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68Ga-FAP-RGD PET/CT : Dosimetry and Preliminary Clinical Translational Studies in Cancer Patients

Conditions
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Tumor

Intervention / Treatment
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* Drug: 68Ga-FAP-RGD
* Drug: 68Ga-FAP-RGD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Various solid tumors with available histopathological findings Signed informed consent Exclusion Criteria: pregnant or lactational women who suffered from severe hepatic and renal insufficiency

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part I: safety, tolerability, biodistribution and dosimetry<br>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<br>* The dose will be 4-7mCi given intravenously.<br>|
| Experimental: Part II: diagnostic efficacy<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Human biodistribution | 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) | From right after tracer injection to 2-hours post-injection | 
| Human dosimetry | 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. | From right after tracer injection to 2-hours post-injection | 
| Standard uptake value (SUV) | Determination of SUV for detected lesions and discernible organs of 68Ga-FAP-RGD and 68Ga-FAPI-02 or 18F-FDG | Up to 2 weeks | 
| Lesion numbers | Determination of lesion numbers of 68Ga-FAP-RGD and 68Ga-FAPI-02 or 18F-FDG | Up to 2 weeks | 
| the sensitivity of 68Ga-FAP-RGD PET/CT | compared with pathology or composite imaging, the sensitivity of 68Ga-FAP-RGD PET/CT was evaluated. | Up to 2 weeks | 
| the specificity of 68Ga-FAP-RGD PET/CT | compared with pathology or composite imaging, the specificity of 68Ga-FAP-RGD PET/CT was evaluated. | Up to 2 weeks | 
| the accuracy of 68Ga-FAP-RGD PET/CT | compared with pathology or composite imaging, the accuracy of 68Ga-FAP-RGD PET/CT was evaluated. | Up to 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Count of participants with treatment emergent adverse events | 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 | Up to 3 days |