Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2026-05-25 @ 8:37 PM
Study NCT ID:
NCT02939456
Status:
COMPLETED
Last Update Posted:
2019-03-14
First Post:
2016-10-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Of DIR-MRI And DCE-MRI In Detection Of Prostate Cancer: A Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}], 'ancestors': [{'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2017-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-12', 'studyFirstSubmitDate': '2016-10-18', 'studyFirstSubmitQcDate': '2016-10-18', 'lastUpdatePostDateStruct': {'date': '2019-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lesion to Normal tissue Ratio (LNR) recorded for DIR-MRI and DCE-MRI', 'timeFrame': '3 months', 'description': 'In order to inform a sample size calculation for a subsequent, fully powered equivalence trial Is DIR-MRI equivalent to DCE-MRI in detection of prostate cancer'}], 'secondaryOutcomes': [{'measure': 'Correlation of biopsy and DIR-MRI and DCE-MRI findings', 'timeFrame': '3 months', 'description': 'In order to ascertain if addition of DIR-MRI could improve accuracy of cancer diagnosis'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['prostate', 'cancer', 'MRI'], 'conditions': ['Cancer of the Prostate']}, 'descriptionModule': {'briefSummary': 'This is a pilot study taking place at University Hospitals of North Midlands NHS Trust. Patients referred for MRI for possible prostate cancer will be invited to take part in the study. Following consent, participants will have an additional MRI sequence performed during their routine MRI called Double Inversion Magnetic Resonance Imaging (DIR-MRI).\n\nParticipants scan images and prostate biopsy histology report (if applicable) will be reviewed by the research team.', 'detailedDescription': 'This is a pilot study taking place at University Hospitals of North Midlands NHS Trust. Patients referred for MRI for possible prostate cancer will be invited to take part in the study. Following consent, participants will have an additional MRI sequence performed during their routine MRI called Double Inversion Magnetic Resonance Imaging (DIR-MRI). Participants scan images and prostate biopsy histology report (if applicable) will be reviewed by the research team. The research team will look at the variability of LNR score amongst the two scan typed and the DCE-MRI and DIR-MRI images will be correlated with biopsy results to give an indication of the accuracy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients referred for prostate MRI for possible prostate cancer\n* Safe to undergo an MRI scan\n* Able to give informed consent\n\nExclusion Criteria:\n\n* MRI referrals where prostate cancer is not the question\n* Patients who are not safe to undergo an MRI scan\n* Patients who have undergone prostate biopsy in the previous 10 weeks\n* Patients unable to give informed consent'}, 'identificationModule': {'nctId': 'NCT02939456', 'acronym': 'DIRMP', 'briefTitle': 'Comparison Of DIR-MRI And DCE-MRI In Detection Of Prostate Cancer: A Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'University Hospitals of North Midlands NHS Trust'}, 'officialTitle': 'Comparison Of Double Inversion Recovery Magnetic Resonance Imaging (Dir-Mri) And Dynamic Contrast Enhanced Magnetic Imaging (Dce-Mri) In Detection Of Prostate Cancer: A Pilot Study', 'orgStudyIdInfo': {'id': '1139'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'DIR-MRI', 'description': 'Participants will have Double Inversion Recovery Magnetic Resonance Imaging (DIR-MRI) as well as the standard Dynamic Contrast Enhanced Magnetic Imaging (DCE-MRI)', 'interventionNames': ['Other: Magnetic Resonance Imaging']}], 'interventions': [{'name': 'Magnetic Resonance Imaging', 'type': 'OTHER', 'description': 'Double Inversion Recovery Magnetic Resonance Imaging (DIR-MRI) and Dynamic Contrast Enhanced Magnetic Imaging (DCE-MRI)', 'armGroupLabels': ['DIR-MRI']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'ST4 6QG', 'city': 'Stoke-on-Trent', 'state': 'Staffordshire', 'country': 'United Kingdom', 'facility': 'University Hospitals of North Midlands NHS Trust', 'geoPoint': {'lat': 53.00415, 'lon': -2.18538}}], 'overallOfficials': [{'name': 'Eric Onwuharine', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospitals of North Midlands NHS Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospitals of North Midlands NHS Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}