WithdrawnNot Applicable

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

Stopped: lack of funding

United States0Started 2017-04-25

Plain-language 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.

Who can participate

Age range

18 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 2 Months

T2 relaxation time using PET/MRI fusion

Timeframe: 2 Months

Metabolite concentration using PET/MRI fusion

Timeframe: 2 Months

Spectroscopy of the testis using PET/MRI fusion

Timeframe: 2 Months

Trial details

NCT IDNCT02669108

SponsorNYU Langone Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-04-25

View on ClinicalTrials.gov More Infertility trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.