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

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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02669108

Enrollment

Registered

2016-01-29

Start date

2017-04-25

Completion date

2017-04-25

Last updated

2017-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility, Non-obstructive Azoospermia, Vasectomy

Keywords

testis, spermatogenesis

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.

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).

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026