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

May 13, 2018 updated by: Xiangya Hospital of Central South University
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

65

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • China, Hunan
      • Changsha, China, Hunan, China, 410008
        • Recruiting
        • Department of PET Center,Xiangya Hospital,Central South University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 18F-AlF-NOTA-NT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xiangya Hospital of Central South University

Investigators

  • Principal Investigator: Yongxiang Tang, MD, Department of PET Center,Xiangya Hospital,Central South University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 23, 2018

Primary Completion (Anticipated)

December 30, 2019

Study Completion (Anticipated)

December 30, 2020

Study Registration Dates

First Submitted

April 23, 2018

First Submitted That Met QC Criteria

April 23, 2018

First Posted (Actual)

May 4, 2018

Study Record Updates

Last Update Posted (Actual)

May 17, 2018

Last Update Submitted That Met QC Criteria

May 13, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201801002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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