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

Overview

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).

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 30, 2019

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).

Interventions

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

Arms, Groups and Cohorts

  • Experimental: 18F-AlF-NOTA-neurotensin PET/CT
    • 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

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • 18F-AlF-NOTA-neurotensin PET/CT prognostic factor for overall and disease specific survival
    • Time Frame: 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.

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Xiangya Hospital of Central South University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Yongxiang Tang, MD, Principal Investigator, Department of PET Center,Xiangya Hospital,Central South University
  • Overall Contact(s)
    • Yongxiang Tang, MD, +86 13549654360, yxtang@csu.edu.cn

References

Maschauer S, Einsiedel J, Hubner 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.

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.

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.

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