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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: 18F-AlF-NOTA-neurotensin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically and/or clinically confirmed and/or suspicious of PCa. Signed informed consent. Exclusion Criteria: Claustrophobia (unable to accept PET/CT scanning)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 18F-AlF-NOTA-neurotensin PET/CT<br>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<br>* One injection of the radioligand 18F-AlF-NOTA-neurotensin<br>* Other names: 18F-AlF-NOTA-NT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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18F-AlF-NOTA-neurotensin