Non-invasive Detection of Male Infertility With FDG-PET/MRI (Spectroscopy and DWI)

Sponsor
Rigshospitalet, Denmark (Other)
Overall Status
Recruiting
CT.gov ID
NCT03250195
Collaborator
(none)
20
1
1
48
0.4

Study Details

Study Description

Brief Summary

The aim of the study is to examine the value of the new MRI techniques (spectroscopy and DWI), and FDG-PET in prognostication of male infertility.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: PET/MRI
N/A

Detailed Description

The diagnostic workup of male infertility includes medical history, physical examination and semen analysis. In severe cases further workup includes testicular ultrasound, analysis of genes and hormones and in a few cases testicular biopsies are necessary.

Ultrasound is the first choice of imaging, but new MRI and PET techniques can provide additional information.

Research indicates that new MRI techniques can measure the activity of the testicular sperm cell production non-invasively and FDG-PET can measure the testicular metabolism with a radioactively marked glucose analog (FDG). These imaging modalities are combined in a PET/MRI and we wish to perform a PET/MRI in 10 men with normal sperm counts and 10 men with low sperm counts in order to evaluate whether a PET/MRI can distinguish testicles with and without sperm cell production. We hope that this new non-invasive technique can replace the need for invasive biopsies and will be able to target the harvesting of sperm cells in fertility treatment.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Non-invasive Detection of Male Infertility With FDG-PET/MRI (Spectroscopy and DWI)
Actual Study Start Date :
Aug 7, 2017
Anticipated Primary Completion Date :
Aug 7, 2021
Anticipated Study Completion Date :
Aug 7, 2021

Arms and Interventions

Arm Intervention/Treatment
Other: PET/MRI

All participants will have a PET/MRI performed

Diagnostic Test: PET/MRI
PET/MRI scan

Outcome Measures

Primary Outcome Measures

  1. SUVmax (maximum standardized uptake value) [1 year]

    The SUV is the ratio of the image derived radioactivity concentration and the whole body concentration of the injected radioactivity.

  2. Testicular metabolite concentrations measured by MRI spectroscopy. [1 year]

    MR spectroscopy is a non-invasive, ionizing-radiation-free analytical technique that has been used to study metabolic changes in different tissues. The unit is p.p.m.

  3. Testicular apparent diffusion coefficient [1 year]

    Diffusion-weighted magnetic resonance imaging (DW MRI) provides image contrast that is dependent on the random microscopic motion of water protons, which may be substantially altered by different pathological process.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

18-40 year old males referred to fertility treatment at Rigshospitalet, Denmark. 10 men with a normal sperm count and 10 men with no sperm cells in the ejaculate will be included. The patients shall be able to understand the patient information and be able to give informed consent.

Exclusion Criteria:

Severe claustrophobia Age: less than 18 or above 40 Severe obesity (> 140 kg) Pacemaker or other electronic in-operated devices Non-MR compatible metallic devices Malignant testicular tumors suspected at clinical examination or ultrasound Infectious testicular diseases

Contacts and Locations

Locations

Site City State Country Postal Code
1 Rigshospitalet Copenhagen Østerbro Denmark 2100

Sponsors and Collaborators

  • Rigshospitalet, Denmark

Investigators

  • Principal Investigator: Louise Risør, Rigshospitalet, Denmark

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Louise Madeleine Risør, MD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT03250195
Other Study ID Numbers:
  • H-17013319
First Posted:
Aug 15, 2017
Last Update Posted:
Oct 8, 2020
Last Verified:
Oct 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 8, 2020