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

NYU Langone Health

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Conditions

Infertility Non-obstructive Azoospermia Vasectomy

Interventions

PET/ MRI of the TestisDEVICE

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).

Eligibility

Sex: MALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

New York University School of Medicine

New York, New York, United States

Outcomes

Primary Outcomes

Diffusion-weighted coefficient imaging of testis using PET/MRI fusion

Time frame: 2 Months

T2 relaxation time using PET/MRI fusion

Time frame: 2 Months

Metabolite concentration using PET/MRI fusion

Time frame: 2 Months

Spectroscopy of the testis using PET/MRI fusion

Time frame: 2 Months

Data from ClinicalTrials.gov

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