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

April 25, 2017 updated by: NYU Langone Health

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

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 Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • New York University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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).
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).

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Investigators

  • Principal Investigator: Joseph Alukal, MD, New York University Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 25, 2017

Primary Completion (Actual)

April 25, 2017

Study Completion (Actual)

April 25, 2017

Study Registration Dates

First Submitted

January 27, 2016

First Submitted That Met QC Criteria

January 27, 2016

First Posted (Estimate)

January 29, 2016

Study Record Updates

Last Update Posted (Actual)

April 27, 2017

Last Update Submitted That Met QC Criteria

April 25, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-01636

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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