Non-invasive Detection of Male Infertility With FDG-PET/MRI (Spectroscopy and DWI)
Primary Purpose
Fertility Disorders
Status
Terminated
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
PET/MRI
Sponsored by
About this trial
This is an interventional diagnostic trial for Fertility Disorders
Eligibility Criteria
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
Sites / Locations
- Rigshospitalet
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
PET/MRI
Arm Description
All participants will have a PET/MRI performed
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03250195
First Posted
August 7, 2017
Last Updated
November 1, 2022
Sponsor
Rigshospitalet, Denmark
1. Study Identification
Unique Protocol Identification Number
NCT03250195
Brief Title
Non-invasive Detection of Male Infertility With FDG-PET/MRI (Spectroscopy and DWI)
Official Title
Non-invasive Detection of Male Infertility With FDG-PET/MRI (Spectroscopy and DWI)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Terminated
Why Stopped
Insufficient inclusion of patients
Study Start Date
August 7, 2017 (Actual)
Primary Completion Date
August 7, 2021 (Actual)
Study Completion Date
August 7, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fertility Disorders
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PET/MRI
Arm Type
Other
Arm Description
All participants will have a PET/MRI performed
Intervention Type
Diagnostic Test
Intervention Name(s)
PET/MRI
Intervention Description
PET/MRI scan
Primary Outcome Measure Information:
Title
SUVmax (maximum standardized uptake value)
Description
The SUV is the ratio of the image derived radioactivity concentration and the whole body concentration of the injected radioactivity.
Time Frame
1 year
Title
Testicular metabolite concentrations measured by MRI spectroscopy.
Description
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.
Time Frame
1 year
Title
Testicular apparent diffusion coefficient
Description
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.
Time Frame
1 year
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
We examine testicular function and therefore we only include men
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louise Risør
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rigshospitalet
City
Copenhagen
State/Province
Østerbro
ZIP/Postal Code
2100
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The results will be published in international journals
Learn more about this trial
Non-invasive Detection of Male Infertility With FDG-PET/MRI (Spectroscopy and DWI)
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