A Study of 18F-AlF-NOTA-Neurotensin PET/CT for Imaging Prostate Cancer

Phase 1

• Conditions: Prostate Cancer
• Interventions: Drug: 18F-AlF-NOTA-neurotensin

• Registration Number: NCT03516045
• Lead Sponsor: Xiangya Hospital of Central South University

Brief Summary

The aim of this study is to investigate the clinical value of \[18F\]aluminum fluoride-1,4,7-triazacyclononane-1,4,7-triacetic acid-neurotensin（18F-AlF-NOTA-neurotensin）positron emission tomography / computed tomography (PET/CT) in patients with prostate cancer (PCa).

Detailed Description

18F-AlF-NOTA-neurotensin is a radioligand targeting the neurotensinreceptor, which is widely expressed on the cell surface of PCa. The radioligand can be used for the diagnosis and stage of the PCa. A total of 5 volunteers and 60 PCa patients will be subjected to a 18F-AlF-NOTA-neurotensin PET/CT scan. The uptake of 18F-AlF-NOTA-neurotensin in organs and tumor lesions will be quantified as Standardized Uptake Values (SUVmax/SUVmean).

Study Timeline

• Status Verified: 2018-04
• Study Start: 2018-04-23
• Study First Submitted: 2018-04-23
• Study First Submitted QC: 2018-04-23
• Study First Posted: 2018-05-04
• Last Update Submitted: 2018-05-13
• Last Update Posted: 2018-05-17
• Primary Completion: 2019-12-30
• Study Completion: 2020-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

1. Histologically and/or clinically confirmed and/or suspicious of PCa.
2. Signed informed consent.

Exclusion Criteria

Claustrophobia (unable to accept PET/CT scanning)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
18F-AlF-NOTA-neurotensin PET/CT	18F-AlF-NOTA-neurotensin	One injection of the radioligand 18F-AlF-NOTA-neurotensin Device: PET/CT Following injection of 18F-AlF-NOTA-neurotensin the participants will be subjected to whole body PET/CT

Primary Outcome Measures

Name	Time	Method
18F-AlF-NOTA-neurotensin PET/CT imaging of patients with Prostate Cancer	12 months	The radioligand 18F-AlF-NOTA-neurotensin can be used to visualize prostate cancer

Secondary Outcome Measures

Name	Time	Method
18F-AlF-NOTA-neurotensin PET/CT prognostic factor for overall and disease specific survival	24 months	The standard uptake value (SUV) of the 18F-AlF-NOTA-neurotensin in prostate cancer lesions is associated with Gleason score, staging and risk stratification of prostate cancer.; SUV (g/mL)=Cimg / (ID/BW) ; Cimg is the prostate cancer pixel intensities of a calibrated PET image (MBq/ml), ID is the injected dose or injected radioactivity (MBq),BW is the body weight (g) .; Gleason score of a prostate biopsy or radical prostatectomy.

Trial Locations

Locations (1)

Department of PET Center,Xiangya Hospital,Central South University; 🇨🇳 Changsha, China, Hunan, China