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

NCT03250195 | Terminated

• 1 other identifier: H-17013319
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Fertility Disorders

Outcome Measures

Primary Outcomes (3)

• SUVmax (maximum standardized uptake value)

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

  1 year

• Testicular metabolite concentrations measured by MRI spectroscopy.

  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.

  1 year

• Testicular apparent diffusion coefficient

  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.

  1 year

Study Arms (1)

PET/MRI

OTHER

All participants will have a PET/MRI performed

Diagnostic Test: PET/MRI

Interventions

PET/MRI DIAGNOSTIC_TEST

PET/MRI scan

PET/MRI

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: We examine testicular function and therefore we only include men
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet

Copenhagen, Østerbro, 2100, Denmark

Location

Study Officials

• Louise Risør

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 7, 2017
• First Posted: August 15, 2017
• Study Start: August 7, 2017
• Primary Completion: August 7, 2021
• Study Completion: August 7, 2021
• Last Updated: November 4, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)