Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2026-02-25 @ 9:40 PM
Study NCT ID:
NCT01992718
Status:
COMPLETED
Last Update Posted:
2018-05-31
First Post:
2013-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
What Are we Missing? Diagnosing Uterine Adenomyosis Using Ultrasound Elastography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014592', 'term': 'Uterine Hemorrhage'}, {'id': 'D007889', 'term': 'Leiomyoma'}, {'id': 'D062788', 'term': 'Adenomyosis'}], 'ancestors': [{'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009379', 'term': 'Neoplasms, Muscle Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019220', 'term': 'High-Energy Shock Waves'}], 'ancestors': [{'id': 'D000069453', 'term': 'Ultrasonic Waves'}, {'id': 'D013016', 'term': 'Sound'}, {'id': 'D011840', 'term': 'Radiation, Nonionizing'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-30', 'studyFirstSubmitDate': '2013-11-07', 'studyFirstSubmitQcDate': '2013-11-19', 'lastUpdatePostDateStruct': {'date': '2018-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic accuracy of MRI and ultrasound elastography for distinguishing adenomyosis and fibroids', 'timeFrame': '1-2 months per patient', 'description': 'Arm 1 patients will undergo hysterectomy (per previously defined clinical decision unrelated to the study) 4-6 weeks after enrollment and imaging tests, allowing us to correlate imaging and pathologic findings'}], 'secondaryOutcomes': [{'measure': 'Patient preference between ultrasound and MRI', 'timeFrame': '6 months per patient', 'description': 'Patients will take a survey to assess their experiences and preferences for pelvic imaging tests within 6 months after having those tests'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Uterine Bleeding', 'Uterine Fibroids', 'Adenomyosis']}, 'descriptionModule': {'briefSummary': 'To improve the clinical care of women with pelvic pain and abnormal uterine bleeding due to benign uterine conditions including leiomyomas (uterine fibroids) and adenomyosis by evaluating the accuracy of radiology diagnostic exams (MRI(magnetic resonance imaging), ultrasound and ultrasound with elastography).', 'detailedDescription': 'Currently benign conditions of the uterus are frequently underdiagnosed or misdiagnosed. This project will help determine which diagnostic radiology exams are most helpful to the clinician in providing accurate diagnosis. In addition, this study will evaluate which exam (MRI vs. Ultrasound) patients prefer over another exam.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. 18 years of age or older\n2. Pelvic pain and/or abnormal uterine bleeding. (this is specific for Arm. 1 of this study)\n3. If you have had or are scheduled to have both a pelvic MRI (magnetic resonance imaging) and a pelvic ultrasound with 6 months of the time of enrollment. (this is specific to Arm 2 of this study).\n\n \\-\n\nExclusion Criteria:\n\n1. If you are post-menopausal(have not had a period in at least one year's time).\n2. If you have been diagnosed with gynecological malignancy such as uterine, endometrial, cervical or ovarian cancer.\n3. If you are unable or unwilling to sign the informed consents\n4. If you are unable to undergo the research study exams -"}, 'identificationModule': {'nctId': 'NCT01992718', 'briefTitle': 'What Are we Missing? Diagnosing Uterine Adenomyosis Using Ultrasound Elastography', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'What Are we Missing? Diagnosing Uterine Adenomyosis Using Ultrasound Elastography', 'orgStudyIdInfo': {'id': 'HUM00076620'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Evaluation of MRI, US for pelvic conditions', 'description': 'MRI and ultrasound imaging will be used clinically to evaluate pelvic pain and abnormal uterine bleeding. The goal is to determine which exams are most helpful to the clinician in providing an accurate diagnosis as well as evaluating patient preference.', 'interventionNames': ['Procedure: Evaluation of MRI, US for pelvic and uterine conditions']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Patient preference MRI vs. US', 'description': 'We are asking subjects to evaluate patient preference between MRI (magnetic resonance imaging) and ultrasound to determine which they would rather undergo.', 'interventionNames': ['Procedure: Patient preference between MRI and Ultrasound']}], 'interventions': [{'name': 'Evaluation of MRI, US for pelvic and uterine conditions', 'type': 'PROCEDURE', 'description': 'Pelvic ultrasound with transabdominal and transvaginal imaging. The transvaginal ultrasound will include elastography (TVUS-E). Also, a pelvic MRI will be performed if not done in the last 6 months. The MRI is performed with IV gadolinium-based contrast (MultiHance ®).\n\nA patient survey will be included.', 'armGroupLabels': ['Evaluation of MRI, US for pelvic conditions']}, {'name': 'Patient preference between MRI and Ultrasound', 'type': 'PROCEDURE', 'description': 'Subjects may take part in this arm because they have recently had a MRI performed and scheduled for, or have recently undergone a pelvic ultrasound.\n\nSubjects will also be asked to complete a survey that will state their preference with regards to examination/imaging. This will be done over the phone and will take no longer than 30 minutes to complete.', 'armGroupLabels': ['Patient preference MRI vs. US']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Hospital', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Katherine Maturen, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Association of University Radiologists', 'class': 'UNKNOWN'}, {'name': 'GE Radiology Research Academic Fellowship', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Katherine Maturen, M.D.', 'investigatorAffiliation': 'University of Michigan'}}}}