Tumor
Conditions
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.
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.
Interventions
DRUG68Ga-FAP-RGD
The dose will be 4-7mCi given intravenously.
Sponsors
First Affiliated Hospital of Fujian Medical University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
Primary ContactWeibing Miao, MD
Backup ContactJie Zang, MD,PhD
Outcome results
None listed