Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05543317
Other study ID # 2022KY007
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2022
Est. completion date December 31, 2022

Study information

Verified date September 2022
Source The First Affiliated Hospital of Xiamen University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

As a new dual receptor (integrin αvβ3 and FAP) targeting PET radiotracer, 68Ga-FAPI-RGD is promising as an excellent imaging agent applicable to various cancers. In this research, we investigate the safety, biodistribution and radiation dosimetry of 68Ga-FAPI-RGD in healthy volunteers. Moreover, we evaluate the potential usefulness of 68Ga-FAPI-RGD positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various types of cancer, and compared with 18F-FDG PET/CT.


Description:

As a new dual receptor (integrin αvβ3 and FAP) targeting PET radiotracer, 68Ga-FAPI-RGD is promising as an excellent imaging agent applicable to various cancers. In this research, we investigate the safety, biodistribution and radiation dosimetry of 68Ga-FAPI-RGD in healthy volunteers. Moreover, Subjects with various types of cancer underwent contemporaneous 68Ga-FAPI-RGD and 18F-FDG PET/CT either for an initial assessment or for recurrence detection. Tumor uptake was quantified by the maximum standard uptake value (SUVmax). The numbers of positive tumor lesions of 18F-FDG and 68Ga-FAPI-RGD PET/CT were recorded by visual interpretation. The diagnostic accuracy of 68Ga-FAPI-RGD were calculated and compared to 18F-FDG PET/CT.


Recruitment information / eligibility

Status Completed
Enrollment 27
Est. completion date December 31, 2022
Est. primary completion date December 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - adult patients (aged 18 years or order); - patients with suspected or newly diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report); - patients who had scheduled both 18F-FDG and 68Ga-FAPI-RGD PET/CT scans; - 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: - patients with non-malignant lesions; - patients with pregnancy; - the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
18F-FDG PET/CT, 68Ga-FAPI-RGD PET/CT
Each subject receives a single intravenous injection of 18F-FDG and 68Ga-FAP-RGD, and undergo PET/CT imaging within the specified time. A part of participants will undergo additional 68Ga-FAPI-46 PET/CT for comparison.

Locations

Country Name City State
China The First Affiliated Hospital of Xiamen University Xiamen Fujian

Sponsors (1)

Lead Sponsor Collaborator
The First Affiliated Hospital of Xiamen University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Diagnostic efficacy The sensitivity, specificity, and accuracy of 18F-FDG and 68Ga-FAPI-RGD PET/CT were calculated and compared to evaluate the diagnostic accuracy. 30 days
Secondary Number of lesions The numbers of positive primary and metastatic lesions of 18F-FDG and 68Ga-FAPI-RGD PET/CT were recorded by visual interpretation. 30 days
Secondary SUV Standardized uptake value (SUV) of 18F-FDG and 68Ga-FAPI-RGD PET/CT for each target lesion of subject or suspected primary tumor or/and metastasis. 7 days
See also
  Status Clinical Trial Phase
Recruiting NCT05094804 - A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents Phase 1/Phase 2
Recruiting NCT05637034 - 68Ga-DOTA-F2 PET/CT in Patients With Various Types of Cancer N/A
Terminated NCT04095091 - Real-time Tumor Localization and Guidance for Radiotherapy Using Ultrasound (US) and Magnetic Resonance (MR)
Recruiting NCT05378425 - A Study of NTX-1088, a Monoclonal Antibody Targeting the Poliovirus Receptor (PVR, CD155), as Monotherapy and Combined With Pembrolizumab Phase 1
Not yet recruiting NCT04723810 - TumorGlow Intraoperative Molecular Imaging (IMI) Phase 1/Phase 2
Recruiting NCT06116032 - Immune Profiling for Cancer Immunotherapy Response
Recruiting NCT06090266 - A Study of OR502, a Monoclonal Antibody Targeting LILRB2, Alone and in Combination With Anticancer Agents Phase 1/Phase 2
Recruiting NCT04416165 - Comparison of FDG and FAPI in Patients With Various Types of Cancer N/A
Recruiting NCT05620134 - Study of JK08 in Patients With Unresectable Locally Advanced or Metastatic Cancer Phase 1/Phase 2
Recruiting NCT04750772 - Positron Nuclide Labeled DOTA-FAPI PET Study in Colocrectal Cancer N/A
Recruiting NCT06022029 - A Dose Escalation and Dose Expansion Study of Intratumoral ONM-501 Alone and in Combination With Cemiplimab in Patients With Advanced Solid Tumors and Lymphomas. Phase 1
Terminated NCT01358331 - A Study of the Safety, Tolerability, and Efficacy of MK-8353 in Participants With Advanced Solid Tumors (MK-8353-001) Phase 1
Recruiting NCT06175221 - Autologous TLPO Vaccine Basket Phase 2
Recruiting NCT05661461 - Dose-escalation Study to Assess Safety and Pharmacokinetics of Nab-Sirolimus in Patients With Locally Advanced or Metastatic Solid Tumors and Moderate Liver Impairment Phase 1
Active, not recruiting NCT04196530 - BDB001-102: Open Label Dose Escalation of BDB001 in Combination w Atezolizumab Phase 1
Not yet recruiting NCT03731390 - GR1405 Injection in Patients With Advanced Solid Tumor or Lymphoma Phase 1
Active, not recruiting NCT03491631 - Phase I Study of SHR9146 + SHR-1210 +/- Apatinib in Patients With Advanced Solid Tumors Phase 1
Recruiting NCT06193902 - LEU01101: Safety and Preliminary Efficacy of LEU011 in Solid Tumours. Phase 1/Phase 2
Active, not recruiting NCT04528836 - First-in-Human Study of the SHP2 Inhibitor BBP-398 in Patients With Advanced Solid Tumors Phase 1
Recruiting NCT05221320 - Trial of Ulixertinib in Combination With Hydroxychloroquine in Patients With Advanced Gastrointestinal (GI) Malignancies Phase 2