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

Primary Purpose

Prostate Cancer

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
18F-AlF-NOTA-neurotensin
Sponsored by
Xiangya Hospital of Central South University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring 18F-AlF-NOTA-neurotensin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Department of PET Center,Xiangya Hospital,Central South UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

18F-AlF-NOTA-neurotensin PET/CT

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
April 23, 2018
Last Updated
May 13, 2018
Sponsor
Xiangya Hospital of Central South University
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1. Study Identification

Unique Protocol Identification Number
NCT03516045
Brief Title
A Study of 18F-AlF-NOTA-Neurotensin PET/CT for Imaging Prostate Cancer
Official Title
A Study of 18F-AlF-NOTA-Neurotensin PET/CT for Imaging Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 23, 2018 (Actual)
Primary Completion Date
December 30, 2019 (Anticipated)
Study Completion Date
December 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xiangya Hospital of Central South University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
18F-AlF-NOTA-neurotensin

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
65 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
18F-AlF-NOTA-neurotensin PET/CT
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
18F-AlF-NOTA-neurotensin
Other Intervention Name(s)
18F-AlF-NOTA-NT
Intervention Description
One injection of the radioligand 18F-AlF-NOTA-neurotensin
Primary Outcome Measure Information:
Title
18F-AlF-NOTA-neurotensin PET/CT imaging of patients with Prostate Cancer
Description
The radioligand 18F-AlF-NOTA-neurotensin can be used to visualize prostate cancer
Time Frame
12 months
Secondary Outcome Measure Information:
Title
18F-AlF-NOTA-neurotensin PET/CT prognostic factor for overall and disease specific survival
Description
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.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Histologically and/or clinically confirmed and/or suspicious of PCa. Signed informed consent. Exclusion Criteria: Claustrophobia (unable to accept PET/CT scanning)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yongxiang Tang, MD
Phone
+86 13549654360
Email
yxtang@csu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Shuo Hu, MD, Phd
Phone
+86 15874210819
Email
hushuo_xy@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yongxiang Tang, MD
Organizational Affiliation
Department of PET Center,Xiangya Hospital,Central South University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of PET Center,Xiangya Hospital,Central South University
City
Changsha
State/Province
China, Hunan
ZIP/Postal Code
410008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yongxiang Tang, MD
Phone
+86 13549654360
Email
yxtang@csu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27336295
Citation
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.
Results Reference
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PubMed Identifier
24854793
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.
Results Reference
background
PubMed Identifier
26162008
Citation
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.
Results Reference
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A Study of 18F-AlF-NOTA-Neurotensin PET/CT for Imaging Prostate Cancer

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