Non-invasive Detection of Male Infertility With FDG-PET/MRI (Spectroscopy and DWI)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Rigshospitalet, Denmark
- Enrollment
- 12
- Locations
- 2
- Primary Endpoint
- SUVmax (maximum standardized uptake value)
Study Overview
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.
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
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- 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
Outcomes
Primary Outcomes
SUVmax (maximum standardized uptake value)
Time Frame: 1 year
The SUV is the ratio of the image derived radioactivity concentration and the whole body concentration of the injected radioactivity.
Testicular metabolite concentrations measured by MRI spectroscopy.
Time Frame: 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.
Testicular apparent diffusion coefficient
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Louise Madeleine Risør
MD
Rigshospitalet, Denmark