NCT02669108

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

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Infertility
• Non-obstructive Azoospermia
• Vasectomy

Interventions

Type	Name	Description
DEVICE	PET/ MRI of the Testis	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).

Timeline

• Start date: 2017-04-25
• Primary completion: 2017-04-25
• Completion: 2017-04-25
• First posted: 2016-01-29
• Last updated: 2017-04-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study