Ignite Creation Date:
2025-12-24 @ 1:21 PM
Ignite Modification Date:
2026-02-17 @ 11:09 PM
Study NCT ID:
NCT03250195
Status:
TERMINATED
Last Update Posted:
2022-11-04
First Post:
2017-08-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-invasive Detection of Male Infertility With FDG-PET/MRI (Spectroscopy and DWI)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'whyStopped': 'Insufficient inclusion of patients', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-08-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2021-08-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-01', 'studyFirstSubmitDate': '2017-08-07', 'studyFirstSubmitQcDate': '2017-08-10', 'lastUpdatePostDateStruct': {'date': '2022-11-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SUVmax (maximum standardized uptake value)', 'timeFrame': '1 year', 'description': 'The SUV is the ratio of the image derived radioactivity concentration and the whole body concentration of the injected radioactivity.'}, {'measure': 'Testicular metabolite concentrations measured by MRI spectroscopy.', 'timeFrame': '1 year', '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.'}, {'measure': 'Testicular apparent diffusion coefficient', 'timeFrame': '1 year', '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fertility Disorders']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nUltrasound is the first choice of imaging, but new MRI and PET techniques can provide additional information.\n\nResearch 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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'We examine testicular function and therefore we only include men', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n18-40 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.\n\nExclusion Criteria:\n\nSevere 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'}, 'identificationModule': {'nctId': 'NCT03250195', 'briefTitle': 'Non-invasive Detection of Male Infertility With FDG-PET/MRI (Spectroscopy and DWI)', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Non-invasive Detection of Male Infertility With FDG-PET/MRI (Spectroscopy and DWI)', 'orgStudyIdInfo': {'id': 'H-17013319'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'PET/MRI', 'description': 'All participants will have a PET/MRI performed', 'interventionNames': ['Diagnostic Test: PET/MRI']}], 'interventions': [{'name': 'PET/MRI', 'type': 'DIAGNOSTIC_TEST', 'description': 'PET/MRI scan', 'armGroupLabels': ['PET/MRI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'state': 'Østerbro', 'country': 'Denmark', 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Louise Risør', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rigshospitalet, Denmark'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The results will be published in international journals'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Louise Madeleine Risør', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}