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

Infertility Clinical Trial

Official title:

PET-MRI for Functional Imaging of the Testis: A New Methodology for Evaluation of the Infertile Male

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02669108
• Other study ID #: 14-01636
• Status: Withdrawn
• Phase: N/A
• First received: January 27, 2016
• Last updated: April 25, 2017
• Start date: April 25, 2017
• Est. completion date: April 25, 2017

Study information

• Verified date: April 2017
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 25, 2017
• Est. primary completion date: April 25, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Azoospermia
• Infertility
• Non-obstructive Azoospermia
• Vasectomy

Intervention

Device:
• 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).

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diffusion-weighted coefficient imaging of testis using PET/MRI fusion		2 Months
Primary	T2 relaxation time using PET/MRI fusion		2 Months
Primary	Metabolite concentration using PET/MRI fusion		2 Months
Primary	Spectroscopy of the testis using PET/MRI fusion		2 Months