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

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ClinicalTrials.gov Identifier: NCT03516045
Recruitment Status : Recruiting
First Posted : May 4, 2018
Last Update Posted : May 17, 2018
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: 18F-AlF-NOTA-neurotensin Phase 1 Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Study of 18F-AlF-NOTA-Neurotensin PET/CT for Imaging Prostate Cancer
Actual Study Start Date : April 23, 2018
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Drug: 18F-AlF-NOTA-neurotensin
One injection of the radioligand 18F-AlF-NOTA-neurotensin
Other Name: 18F-AlF-NOTA-NT




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03516045


Contacts
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Contact: Yongxiang Tang, MD +86 13549654360 yxtang@csu.edu.cn
Contact: Shuo Hu, MD, Phd +86 15874210819 hushuo_xy@163.com

Locations
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China, China, Hunan
Department of PET Center,Xiangya Hospital,Central South University Recruiting
Changsha, China, Hunan, China, 410008
Contact: Yongxiang Tang, MD    +86 13549654360    yxtang@csu.edu.cn   
Sponsors and Collaborators
Xiangya Hospital of Central South University
Investigators
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Principal Investigator: Yongxiang Tang, MD Department of PET Center,Xiangya Hospital,Central South University

Publications:
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Responsible Party: Xiangya Hospital of Central South University
ClinicalTrials.gov Identifier: NCT03516045     History of Changes
Other Study ID Numbers: 201801002
First Posted: May 4, 2018    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Xiangya Hospital of Central South University:
18F-AlF-NOTA-neurotensin

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases