Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part I: safety, tolerability, biodistribution and dosimetry | Experimental | 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 |
|
| Part II: diagnostic efficacy | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 68Ga-FAP-RGD | Drug | The dose will be 4-7mCi given intravenously. |
|
| 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. |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weibing Miao, MD | Contact | 86-0591-87981618 | miaoweibing@126.com | |
| Jie Zang, MD,PhD | Contact | 86-15901495106 | 15901495106@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Weibing Miao, MD | The First Affiliated Hospital, Fujian Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University | Recruiting | Fuzhou | Fujian | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39404790 | Derived | Chen Y, Zheng S, Zang J, Shao Z, Tu D, Liu Q, Chen X, Miao W, Zhang J. [68Ga]Ga-LNC1007 versus 2-[18F]FDG in the evaluation of patients with metastatic differentiated thyroid cancer: a head-to-head comparative study. Eur J Nucl Med Mol Imaging. 2025 Jan;52(2):683-692. doi: 10.1007/s00259-024-06930-4. Epub 2024 Oct 15. | |
| 37682601 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 68Ga-FAP-RGD | Drug | 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. |
|
| Up to 2 weeks |
| Zang J, Lin R, Wen X, Wang C, Zhao T, Jakobsson V, Yang Y, Wu X, Guo Z, Chen X, Zhang J, Miao W. A Head-to-Head Comparison of 68Ga-LNC1007 and 2-18F-FDG/68Ga-FAPI-02 PET/CT in Patients With Various Cancers. Clin Nucl Med. 2023 Oct 1;48(10):861-868. doi: 10.1097/RLU.0000000000004820. Epub 2023 Sep 2. |