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

Sponsor

NYU Langone Health (Other)

Overall Status

Withdrawn

CT.gov ID

NCT02669108

Collaborator

(none)

Enrollment

Location

Arm

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility Non-obstructive Azoospermia Vasectomy	Device: PET/ MRI of the Testis	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Apr 25, 2017

Actual Primary Completion Date :

Apr 25, 2017

Actual Study Completion Date :

Apr 25, 2017

Arms and Interventions

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).

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).

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York University School of Medicine	New York	New York	United States	10016

Sponsors and Collaborators

NYU Langone Health

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

NYU Langone Health

ClinicalTrials.gov Identifier:

NCT02669108

Other Study ID Numbers:

14-01636

First Posted:

Jan 29, 2016

Last Update Posted:

Apr 27, 2017

Last Verified:

Apr 1, 2017

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Keywords provided by NYU Langone Health

testis

spermatogenesis

Additional relevant MeSH terms:

Infertility

Azoospermia

Study Results

No Results Posted as of Apr 27, 2017