PET-MRI for Functional Imaging of the Testis: A Feasibility Study

Study Overview
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Brief Summary
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The primary objective of this study is to explore feasibility of testis functionality assessment and testis imaging obtained from Positron Emissions Tomography (PET) /Magnetic Resonance Imagine (MRI). Using advanced MRI metrics, investigators will study the three-dimensional structure of normal testis, the levels of specific elements and compounds in the tissues (which can only be found via these imaging techniques), and the directionality (and alterations in directionality) of tissue structure. Investigators hope to develop hypothesis that will in turn suggest bio-markers to be explored in subsequent clinical trials.

Official Title
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PET-MRI for Functional Imaging of the Testis: A New Methodology for Evaluation of the Infertile Male

Conditions
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Infertility, Non-obstructive Azoospermia, Vasectomy

Intervention / Treatment
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* Device: PET/ MRI of the Testis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men with proven paternity desiring vasectomy who are over 18 years of age. Exclusion Criteria: Bilaterally absent testes, unilaterally or bilaterally undescended testes Patients who have proven azoospermia or no proven paternity Inability to tolerate MRI including conditions such as claustrophobia or inability to lay flat for > 45 minutes. Presence of pacemaker/IImplantable Cardioverter Defibrillator (ICD) or perfusion pumps Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial heart, valves with steel parts, metal fragments, shrapnel, bullets, tattoos near the eye, or steel implants. Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study All women are excluded as such patients do not have the relevant anatomy being considered in this study Anyone from a vulnerable population will be excluded from the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

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 |
| --- | --- |
| Other: PET/MRI of the Testis<br>PET/MRI of the testis will be performed upon the patient achieving azoospermia (following the vasectomy), or 25 ejaculations and following proven azoospermia (via standard of care semen analysis). | Device: PET/ MRI of the Testis<br>* PET/MRI of the testis will be performed upon the patient achieving azoospermia (following the vasectomy), or 25 ejaculations and following proven azoospermia (via standard of care semen analysis).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diffusion-weighted coefficient imaging of testis using PET/MRI fusion |  | 2 Months | 
| T2 relaxation time using PET/MRI fusion |  | 2 Months | 
| Metabolite concentration using PET/MRI fusion |  | 2 Months | 
| Spectroscopy of the testis using PET/MRI fusion |  | 2 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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testis, spermatogenesis