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WithdrawnNCT02669108Updated Apr 27, 2017

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

An interventional study of PET/ MRI of the Testis in Infertility, Non-obstructive Azoospermia and Vasectomy, sponsored by NYU Langone Health. Withdrawn at 1 site in United States. Open to male participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-04-27.

Sponsored by NYU Langone Health · Not applicable, Interventional, and Diagnostic

Why this study was withdrawn
lack of funding
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years and older
Sex
Male
01

Study 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.

02

Conditions studied

  • Infertility
  • Non-obstructive Azoospermia
  • Vasectomy

Keywords

  • testis
  • spermatogenesis
03

In context

Infertility

2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.

Browse Infertility studies →

Lead sponsor

NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.

Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • 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

Interventions

  • DevicePET/ 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).

06

What researchers measure

Primary outcomes

  1. Diffusion-weighted coefficient imaging of testis using PET/MRI fusion

    Time frame: 2 Months

  2. T2 relaxation time using PET/MRI fusion

    Time frame: 2 Months

  3. Metabolite concentration using PET/MRI fusion

    Time frame: 2 Months

  4. Spectroscopy of the testis using PET/MRI fusion

    Time frame: 2 Months

07

Study locations

1 site
  • New York University School of Medicine
    New York, New York 10016, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 27, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02669108
Lead sponsor
NYU Langone Health
Responsible party
Sponsor
First posted
Jan 29, 2016
Start date
Apr 25, 2017
Primary completion
Apr 25, 2017
Completion
Apr 25, 2017
Last update
Apr 27, 2017

Study contacts

Joseph Alukal, MD
principal investigator · New York University Medical School

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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