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

Not Applicable

Withdrawn

• Conditions: Non-obstructive Azoospermia; Vasectomy; Infertility
• Interventions: Device: PET/ MRI of the Testis

• Registration Number: NCT02669108
• Lead Sponsor: NYU Langone Health

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-01-27
• Study First Submitted QC: 2016-01-27
• Study First Posted: 2016-01-29
• Status Verified: 2017-04
• Study Start: 2017-04-25
• Primary Completion: 2017-04-25
• Study Completion: 2017-04-25
• Last Update Submitted: 2017-04-25
• Last Update Posted: 2017-04-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

• Men with proven paternity desiring vasectomy who are over 18 years of age.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PET/MRI of the Testis	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).

Primary Outcome Measures

Name	Time	Method
Metabolite concentration using PET/MRI fusion	2 Months
T2 relaxation time using PET/MRI fusion	2 Months
Diffusion-weighted coefficient imaging of testis using PET/MRI fusion	2 Months
Spectroscopy of the testis using PET/MRI fusion	2 Months

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States