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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03516045
• Other study ID #: 201801002
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: April 23, 2018
• Est. completion date: December 30, 2020

Study information

• Verified date: April 2018
• Source: Xiangya Hospital of Central South University
• Contact: Yongxiang Tang, MD
• Phone: +86 13549654360
• Email: yxtang[@]csu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 65
• Est. completion date: December 30, 2020
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• 18F-AlF-NOTA-neurotensin
One injection of the radioligand 18F-AlF-NOTA-neurotensin

Locations

Country	Name	City	State
China	Department of PET Center,Xiangya Hospital,Central South University	Changsha	China, Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

References & Publications (3)

Deng H, Wang H, Wang M, Li Z, Wu Z. Synthesis and Evaluation of 64Cu-DOTA-NT-Cy5.5 as a Dual-Modality PET/Fluorescence Probe to Image Neurotensin Receptor-Positive Tumor. Mol Pharm. 2015 Aug 3;12(8):3054-61. doi: 10.1021/acs.molpharmaceut.5b00325. Epub 2015 Jul 21. — View Citation

Maschauer S, Einsiedel J, Hübner H, Gmeiner P, Prante O. (18)F- and (68)Ga-Labeled Neurotensin Peptides for PET Imaging of Neurotensin Receptor 1. J Med Chem. 2016 Jul 14;59(13):6480-92. doi: 10.1021/acs.jmedchem.6b00675. Epub 2016 Jun 30. — View Citation

Wu Z, Li L, Liu S, Yakushijin F, Yakushijin K, Horne D, Conti PS, Li Z, Kandeel F, Shively JE. Facile Preparation of a Thiol-Reactive (18)F-Labeling Agent and Synthesis of (18)F-DEG-VS-NT for PET Imaging of a Neurotensin Receptor-Positive Tumor. J Nucl Med. 2014 Jul;55(7):1178-84. doi: 10.2967/jnumed.114.137489. Epub 2014 May 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	18F-AlF-NOTA-neurotensin PET/CT imaging of patients with Prostate Cancer	The radioligand 18F-AlF-NOTA-neurotensin can be used to visualize prostate cancer	12 months
Secondary	18F-AlF-NOTA-neurotensin PET/CT prognostic factor for overall and disease specific survival	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.	24 months