A Study of 18F-AlF-NOTA-Neurotensin PET/CT for Imaging Prostate Cancer
1 other identifier
interventional
65
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 prostate-cancer
Started Apr 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 23, 2018
CompletedStudy Start
First participant enrolled
April 23, 2018
CompletedFirst Posted
Study publicly available on registry
May 4, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2020
CompletedMay 17, 2018
April 1, 2018
1.7 years
April 23, 2018
May 13, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
18F-AlF-NOTA-neurotensin PET/CT prognostic factor for overall and disease specific survival
24 months
Study Arms (1)
18F-AlF-NOTA-neurotensin PET/CT
EXPERIMENTALOne 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
Interventions
One injection of the radioligand 18F-AlF-NOTA-neurotensin
Eligibility Criteria
You may qualify if:
- Histologically and/or clinically confirmed and/or suspicious of PCa.
- Signed informed consent.
You may not qualify if:
- Claustrophobia (unable to accept PET/CT scanning)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of PET Center,Xiangya Hospital,Central South University
Changsha, China, Hunan, 410008, China
Related Publications (3)
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.
PMID: 27336295BACKGROUNDWu 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.
PMID: 24854793BACKGROUNDDeng 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.
PMID: 26162008BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yongxiang Tang, MD
Department of PET Center,Xiangya Hospital,Central South University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2018
First Posted
May 4, 2018
Study Start
April 23, 2018
Primary Completion
December 30, 2019
Study Completion
December 30, 2020
Last Updated
May 17, 2018
Record last verified: 2018-04
Data Sharing
- IPD Sharing
- Will not share