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

NCT02669108 | Withdrawn FDA Device

• 1 other identifier: 14-01636
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility; Non-obstructive Azoospermia; Vasectomy

Keywords

testis; spermatogenesis

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

PET/MRI of the Testis

OTHER

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

Interventions

PET/ MRI of the Testis DEVICE

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).

PET/MRI of the Testis

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Joseph Alukal, MD

  New York University Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2016
• First Posted: January 29, 2016
• Study Start: April 25, 2017
• Primary Completion: April 25, 2017
• Study Completion: April 25, 2017
• Last Updated: April 27, 2017

Record last verified: 2017-04

Locations

US (1)