Back to resultsPET-MRI for Functional Imaging of the Testis: A Feasibility Study
Primary Purpose
Infertility, Non-obstructive Azoospermia, Vasectomy
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PET/ MRI of the Testis
Sponsored by
About this trial
This is an interventional diagnostic trial for Infertility focused on measuring testis, spermatogenesis
Eligibility Criteria
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
Sites / Locations
- New York University School of Medicine
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
PET/MRI of the Testis
Arm Description
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).
Outcomes
Primary Outcome Measures
Diffusion-weighted coefficient imaging of testis using PET/MRI fusion
T2 relaxation time using PET/MRI fusion
Metabolite concentration using PET/MRI fusion
Spectroscopy of the testis using PET/MRI fusion
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02669108
Brief Title
PET-MRI for Functional Imaging of the Testis: A Feasibility Study
Official Title
PET-MRI for Functional Imaging of the Testis: A New Methodology for Evaluation of the Infertile Male
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Withdrawn
Why Stopped
lack of funding
Study Start Date
April 25, 2017 (Actual)
Primary Completion Date
April 25, 2017 (Actual)
Study Completion Date
April 25, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Non-obstructive Azoospermia, Vasectomy
Keywords
testis, spermatogenesis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PET/MRI of the Testis
Arm Type
Other
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
PET/ MRI of the Testis
Intervention Description
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).
Primary Outcome Measure Information:
Title
Diffusion-weighted coefficient imaging of testis using PET/MRI fusion
Time Frame
2 Months
Title
T2 relaxation time using PET/MRI fusion
Time Frame
2 Months
Title
Metabolite concentration using PET/MRI fusion
Time Frame
2 Months
Title
Spectroscopy of the testis using PET/MRI fusion
Time Frame
2 Months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Alukal, MD
Organizational Affiliation
New York University Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Learn more about this trial
PET-MRI for Functional Imaging of the Testis: A Feasibility Study
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