InfertilityNCT02669108
PET-MRI for Functional Imaging of the Testis: A Feasibility Study
A study testing PET/ MRI of the Testis in people with Infertility and Non-obstructive Azoospermia, run by NYU Langone Health at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Non-obstructive Azoospermia, Vasectomy
- What is being tested?
- PET/ MRI of the Testis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Apr 2017to 25 Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men with proven paternity desiring vasectomy who are over 18 years of age.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Official title: 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.
- Conditions
- Infertility, Non-obstructive Azoospermia, Vasectomy
- Being tested
- PET/ MRI of the Testis
- Keywords
- testis, spermatogenesis
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/ MRI of the TestisDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: PET/ MRI of the Testis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diffusion-weighted coefficient imaging of testis using PET/MRI fusion
Measured: 2 Months
T2 relaxation time using PET/MRI fusion
Measured: 2 Months
Metabolite concentration using PET/MRI fusion
Measured: 2 Months
Spectroscopy of the testis using PET/MRI fusion
Measured: 2 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2016 (estimated)
- Study start25 Apr 2017
- Primary completion25 Apr 2017
- Study completion25 Apr 2017
Why it stopped: lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph Alukal, MD, Principal investigator, New York University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02669108
- Sponsor's protocol ID
- 14-01636
- Status last verified
- Apr 2017
- First submitted
- 27 Jan 2016
- Last updated
- 27 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET-MRI for Functional Imaging of the Testis: A New Methodology for Evaluation of the Infertile Male
- ClinicalTrials.gov ID
- NCT02669108
- Acronym / sponsor ID
- 14-01636
- Conditions
- Infertility, Non-obstructive Azoospermia, Vasectomy
- Keywords
- testis, spermatogenesis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 25 Apr 2017 (actual)
- Primary completion
- 25 Apr 2017 (actual)
- Study completion
- 25 Apr 2017 (actual)
- First posted
- 29 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PET/MRI of the Testis | Other | Device: PET/ MRI of the TestisPET/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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men with proven paternity desiring vasectomy who are over 18 years of age.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET/ MRI of the TestisPET/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 |
Primary outcome
Diffusion-weighted coefficient imaging of testis using PET/MRI fusion
Time frame: 2 Months
T2 relaxation time using PET/MRI fusion
Time frame: 2 Months
Metabolite concentration using PET/MRI fusion
Time frame: 2 Months
Spectroscopy of the testis using PET/MRI fusion
Time frame: 2 Months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Alukal, MD principal investigator
New York University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET/ MRI of the Testis in people with Infertility and Non-obstructive Azoospermia, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diffusion-weighted coefficient imaging of testis using PET/MRI fusion (time frame: 2 Months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2017.