Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2025-12-25 @ 7:07 PM
Study NCT ID:
NCT03573804
Status:
COMPLETED
Last Update Posted:
2021-08-30
First Post:
2018-06-19
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
The Prone to Supine Breast MRI Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'timothy.b.rooney@hitchcock.org', 'phone': '603-650-5000', 'title': 'Timothy B Rooney, MD, PI', 'organization': 'Dartmouth-Hitchcock'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Two weeks after scans', 'eventGroups': [{'id': 'EG000', 'title': 'Prone to Supine MRI', 'description': 'The patient will be placed in the prone position and undergo a standard Gd contrast-enhanced bilateral breast MRI. Immediately after the prone MRI is completed, the patient will be repositioned for the supine MRI. Prior to starting the prone MRI, the study MRI technician/investigator will explain to the patient and practice with the patient the steps needed to transition from the prone to the supine MRI, so as to facilitate a timely transition. Additional MRI images will only take about 10-15 minutes to obtain and will not require a second injection of contrast material.\n\nProne to Supine MRI: The patient will be placed in the prone position and undergo a standard Gd contrast-enhanced bilateral breast MRI. Immediately after the prone MRI is completed, the patient will be repositioned for the supine MRI. Prior to starting the prone MRI, the study MRI technician/investigator will explain to the patient and practice with the patient the steps needed to transition from the prone to the supine MRI, so as to facilitate a timely transition. Additional MRI images will only take about 10-15 minutes to obtain and will not require a second injection of contrast material.', 'otherNumAtRisk': 62, 'deathsNumAtRisk': 62, 'otherNumAffected': 0, 'seriousNumAtRisk': 62, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Successful Segmentation of Supine MRI Images', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prone to Supine MRI Evaluated by Radiologist A', 'description': 'Radiologist A, number of participants successfully segmented'}, {'id': 'OG001', 'title': 'Prone to Supine MRI Evaluated by Radiologist B', 'description': 'Radiologist B, number of participants successfully segmented'}], 'classes': [{'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 minutes', 'description': 'Determine what number of cases that can be successfully segmented both from using post-contrast prone MRI images and also from using post contrast supine MRI images.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Enhancement Quantification, as Measured by Signal Intensity - Segmented Tumor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prone Images', 'description': 'Prone MRI images'}, {'id': 'OG001', 'title': 'Supine Images', 'description': 'Supine MRI images'}], 'classes': [{'categories': [{'measurements': [{'value': '370.09', 'groupId': 'OG000', 'lowerLimit': '63.33', 'upperLimit': '958.31'}, {'value': '594.77', 'groupId': 'OG001', 'lowerLimit': '81.50', 'upperLimit': '1520.94'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '224.675', 'ciLowerLimit': '90.26044', 'ciUpperLimit': '359.08956', 'pValueComment': 'Using an alpha value of 0.05, dof = 60, the null hypothesis of sample mean equivalence was rejected.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '67.89', 'groupDescription': 'Regions of interest (ROIs) for tumor were defined by the radiologist segmentation of tumor in supine and prone positions. ROIs for the surrounding tissue were selected such that tumor and normal regions had equal volumes. The alpha level was assumed to be of 0.05 (dof = 60), and the null hypothesis of equivalence (mu = 0).', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'A paired two-tailed t-test was used on the paired prone-to-supine tumor intensity values.', 'nonInferiorityComment': 'A two-tailed paired T-test for equivalence was used to evaluate equivalence between the average raw tumor.'}], 'paramType': 'MEAN', 'timeFrame': '30 minutes', 'description': 'Compare the signal intensity with that obtained at tumor location on the prone and supine imaging. The amount of enhancement at the tumor site = segmented tumor.', 'unitOfMeasure': 'Tesla per second', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant was not able to complete both the Prone and Supine Imaging and was excluded.'}, {'type': 'SECONDARY', 'title': 'Enhancement Quantification, as Measured by Signal Intensity - Tumor Boundary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prone Images', 'description': 'Prone MRI images'}, {'id': 'OG001', 'title': 'Supine Images', 'description': 'Supine MRI images'}], 'classes': [{'categories': [{'measurements': [{'value': '217.96', 'groupId': 'OG000', 'lowerLimit': '42.3', 'upperLimit': '534.75'}, {'value': '383.80', 'groupId': 'OG001', 'lowerLimit': '35.53', 'upperLimit': '1108.08'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '165.833', 'ciLowerLimit': '78.34708', 'ciUpperLimit': '253.31892', 'pValueComment': 'Using an alpha value of 0.05, dof = 60, the null hypothesis of sample mean equivalence was rejected.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '44.19', 'groupDescription': 'Regions of interest (ROIs) for surrounding tissues were selected as the surrounding benign tissue regions directly adjacent to the segmented tumor regions. Tumor and surrounding regions had equal volumes. The mean surrounding region intensities reported were all calculated from the prone and supine T1-weighted MR images segmented by the radiologist.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'A paired two-tailed t-test was used on the paired prone-to-supine normal tissue intensity values.', 'nonInferiorityComment': 'A two-tailed paired T-test was used to compare sample means in between the prone and supine mean benign tissue intensities.'}], 'paramType': 'MEAN', 'timeFrame': '30 minutes', 'description': 'Compare the signal intensity with that obtained in benign tissue surrounding the tumor on the prone and supine imaging.', 'unitOfMeasure': 'Tesla per second', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant was not able to complete both the Prone and Supine Imaging and was excluded.'}, {'type': 'SECONDARY', 'title': 'Enhancement Quantification- Tumor-to-Background Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prone Images', 'description': 'Prone MRI images'}, {'id': 'OG001', 'title': 'Supine Images', 'description': 'Supine MRI images'}], 'classes': [{'categories': [{'measurements': [{'value': '1.74', 'groupId': 'OG000', 'lowerLimit': '1.07', 'upperLimit': '3.56'}, {'value': '1.62', 'groupId': 'OG001', 'lowerLimit': '0.88', 'upperLimit': '3.86'}]}]}], 'analyses': [{'pValue': '0.0058', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.12', 'ciLowerLimit': '-0.04209', 'ciUpperLimit': '0.28209', 'pValueComment': 'Using an alpha value of 0.05, dof = 60, the null hypothesis of sample mean equivalence was rejected.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.08', 'groupDescription': 'The ratios of tumor-to-surrounding tissue intensities, as calculated in Secondary Objective Part A, were compared between prone and supine T1-weighted MR image scans.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'A two-tailed paired T-test was used to compare sample means in between the prone and supine tumor-to-surrounding tissue ratios.', 'nonInferiorityComment': 'A two-tailed paired T-test was used to compare sample means in between the prone and supine tumor-to-surrounding tissue ratios.'}], 'paramType': 'MEAN', 'timeFrame': '30 minutes', 'description': 'Mean MRI signal of the segmented tumor divided by the mean MRI signal of the surrounding tissue which has an equal volume to the tumor. The difference between tumor and benign breast tissue is the tumor-to-background ratio', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant was not able to complete both the Prone and Supine Imaging and was excluded.'}, {'type': 'SECONDARY', 'title': 'Time to Position and Obtain Supine Images', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Prone to Supine MRI', 'description': 'The patient will be placed in the prone position and undergo a standard Gd contrast-enhanced bilateral breast MRI. Immediately after the prone MRI is completed, the patient will be repositioned for the supine MRI. Prior to starting the prone MRI, the study MRI technician/investigator will explain to the patient and practice with the patient the steps needed to transition from the prone to the supine MRI, so as to facilitate a timely transition. Additional MRI images will only take about 10-15 minutes to obtain and will not require a second injection of contrast material.\n\nProne to Supine MRI: The patient will be placed in the prone position and undergo a standard Gd contrast-enhanced bilateral breast MRI. Immediately after the prone MRI is completed, the patient will be repositioned for the supine MRI. Prior to starting the prone MRI, the study MRI technician/investigator will explain to the patient and practice with the patient the steps needed to transition from the prone to the supine MRI, so as to facilitate a timely transition. Additional MRI images will only take about 10-15 minutes to obtain and will not require a second injection of contrast material.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.25', 'groupId': 'OG000', 'lowerLimit': '5.0', 'upperLimit': '15.92'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '30 Minutes', 'description': 'Calculate the additional time needed to obtain supine MRI images. After the completion of Prone imaging, the patient was removed from the MRI, turned over to the supine position, new coils placed, and returned to the MRI for additional imaging. The aggregate time to accomplish these tasks are noted in minutes.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Comfort for Prone and Supine Positions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall Comfort - Prone Participants.', 'description': 'Quantify the perceived comfort level of the prone MRI as reported by participants.'}, {'id': 'OG001', 'title': 'Overall Comfort Participants - Supine', 'description': 'Quantify the perceived comfort level of the supine MRI as reported by participants.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.82', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '5'}, {'value': '0.61', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '5'}]}]}], 'analyses': [{'pValue': '0.00049664', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Students two-tailed paired t-test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Within 15 minutes of the scan', 'description': 'Quantify the perceived comfort level of the prone and supine MRI as reported by participants. A single question using a Likert scale was was used. The scale range was 0 to 5, where 0 = no pain, completely comfortable and 5 = considerable discomfort.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'This assessment of overall perceived comfort was added to the study during the study period, and only the last 28 patients evaluated their overall comfort with the prone and supine portions of the examination.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Prone to Supine MRI', 'description': 'The patient will be placed in the prone position and undergo a standard Gd contrast-enhanced bilateral breast MRI. Immediately after the prone MRI is completed, the patient will be repositioned for the supine MRI. Prior to starting the prone MRI, the study MRI technician/investigator will explain to the patient and practice with the patient the steps needed to transition from the prone to the supine MRI, so as to facilitate a timely transition. Additional MRI images will only take about 10-15 minutes to obtain and will not require a second injection of contrast material.\n\nProne to Supine MRI: The patient will be placed in the prone position and undergo a standard Gd contrast-enhanced bilateral breast MRI. Immediately after the prone MRI is completed, the patient will be repositioned for the supine MRI. Prior to starting the prone MRI, the study MRI technician/investigator will explain to the patient and practice with the patient the steps needed to transition from the prone to the supine MRI, so as to facilitate a timely transition. Additional MRI images will only take about 10-15 minutes to obtain and will not require a second injection of contrast material.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '72'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'claustrophobia or MRI table problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Prone to Supine MRI', 'description': 'The patient will be placed in the prone position and undergo a standard Gd contrast-enhanced bilateral breast MRI. Immediately after the prone MRI is completed, the patient will be repositioned for the supine MRI. Prior to starting the prone MRI, the study MRI technician/investigator will explain to the patient and practice with the patient the steps needed to transition from the prone to the supine MRI, so as to facilitate a timely transition. Additional MRI images will only take about 10-15 minutes to obtain and will not require a second injection of contrast material.\n\nProne to Supine MRI: The patient will be placed in the prone position and undergo a standard Gd contrast-enhanced bilateral breast MRI. Immediately after the prone MRI is completed, the patient will be repositioned for the supine MRI. Prior to starting the prone MRI, the study MRI technician/investigator will explain to the patient and practice with the patient the steps needed to transition from the prone to the supine MRI, so as to facilitate a timely transition. Additional MRI images will only take about 10-15 minutes to obtain and will not require a second injection of contrast material.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '54', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '72', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '68', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '71', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '72', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-05-07', 'size': 158100, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-04-22T08:13', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2020-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-26', 'studyFirstSubmitDate': '2018-06-19', 'resultsFirstSubmitDate': '2021-07-29', 'studyFirstSubmitQcDate': '2018-06-19', 'lastUpdatePostDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-08-26', 'studyFirstPostDateStruct': {'date': '2018-06-29', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Successful Segmentation of Supine MRI Images', 'timeFrame': '30 minutes', 'description': 'Determine what number of cases that can be successfully segmented both from using post-contrast prone MRI images and also from using post contrast supine MRI images.'}], 'secondaryOutcomes': [{'measure': 'Enhancement Quantification, as Measured by Signal Intensity - Segmented Tumor', 'timeFrame': '30 minutes', 'description': 'Compare the signal intensity with that obtained at tumor location on the prone and supine imaging. The amount of enhancement at the tumor site = segmented tumor.'}, {'measure': 'Enhancement Quantification, as Measured by Signal Intensity - Tumor Boundary', 'timeFrame': '30 minutes', 'description': 'Compare the signal intensity with that obtained in benign tissue surrounding the tumor on the prone and supine imaging.'}, {'measure': 'Enhancement Quantification- Tumor-to-Background Ratio', 'timeFrame': '30 minutes', 'description': 'Mean MRI signal of the segmented tumor divided by the mean MRI signal of the surrounding tissue which has an equal volume to the tumor. The difference between tumor and benign breast tissue is the tumor-to-background ratio'}, {'measure': 'Time to Position and Obtain Supine Images', 'timeFrame': '30 Minutes', 'description': 'Calculate the additional time needed to obtain supine MRI images. After the completion of Prone imaging, the patient was removed from the MRI, turned over to the supine position, new coils placed, and returned to the MRI for additional imaging. The aggregate time to accomplish these tasks are noted in minutes.'}, {'measure': 'Overall Comfort for Prone and Supine Positions', 'timeFrame': 'Within 15 minutes of the scan', 'description': 'Quantify the perceived comfort level of the prone and supine MRI as reported by participants. A single question using a Likert scale was was used. The scale range was 0 to 5, where 0 = no pain, completely comfortable and 5 = considerable discomfort.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast Cancer Locator'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '28766199', 'type': 'BACKGROUND', 'citation': 'Barth RJ Jr, Krishnaswamy V, Paulsen KD, Rooney TB, Wells WA, Rizzo E, Angeles CV, Marotti JD, Zuurbier RA, Black CC. A Patient-Specific 3D-Printed Form Accurately Transfers Supine MRI-Derived Tumor Localization Information to Guide Breast-Conserving Surgery. Ann Surg Oncol. 2017 Oct;24(10):2950-2956. doi: 10.1245/s10434-017-5979-z. Epub 2017 Aug 1.'}, {'pmid': '10713939', 'type': 'BACKGROUND', 'citation': 'Leong CS, Daniel BL, Herfkens RJ, Birdwell RL, Jeffrey SS, Ikeda DM, Sawyer-Glover AM, Glover GH. Characterization of breast lesion morphology with delayed 3DSSMT: an adjunct to dynamic breast MRI. J Magn Reson Imaging. 2000 Feb;11(2):87-96. doi: 10.1002/(sici)1522-2586(200002)11:23.0.co;2-e.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether a supine MRI obtained immediately after a standard diagnostic prone MRI exam, without a second injection of gadolinium (Gd) contrast material, would be of sufficient quality to allow the Radiologist to define the tumor edges ("segment" the tumor) so that a 3-D image of the tumor can be generated to form a BCL.', 'detailedDescription': 'The purpose of this study is to find out whether additional MRI images taken with patients in a different position after completing a standard MRI are of sufficient quality to allow a radiologist to identify the edges of the tumor.\n\nThese additional MRI images will only take about 10-15 minutes to obtain and will not require a second injection of contrast material.The information gathered in this study will make it more feasible to use a new device called the "breast cancer locator" to help surgeons more accurately remove breast cancers.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years.\n* Female gender.\n* Histologic diagnosis of invasive breast cancer or ductal carcinoma in situ\n* Tumor size at least 1 cm in diameter as visualized on mammogram or US.\n* A diagnostic breast MRI is considered to be clinically indicated.\n* Ability to voluntarily provide informed consent to participate prior to any study-related assessments/procedures being conducted.\n\nExclusion Criteria:\n\n* Absolute contraindication to MRI, including presence of implanted electrical device (pacemaker or neurostimulator), aneurysm clip, or metallic foreign body in or near eyes.\n* Severe claustrophobia.\n* Contraindication to use of gadolinium-based intravenous contrast, including life- threatening allergy or compromised renal function (eGFR \\< 30 ml/min/1.73m2).\n* History of median sternotomy.\n* Pregnancy. Patient attestation that they are not pregnant will be acceptable.\n* Patients who have received neoadjuvant chemotherapy.'}, 'identificationModule': {'nctId': 'NCT03573804', 'briefTitle': 'The Prone to Supine Breast MRI Trial', 'organization': {'class': 'OTHER', 'fullName': 'Dartmouth-Hitchcock Medical Center'}, 'officialTitle': 'The Prone to Supine Breast MRI Trial', 'orgStudyIdInfo': {'id': 'D17168'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prone to Supine MRI', 'description': 'The patient will be placed in the prone position and undergo a standard Gd contrast-enhanced bilateral breast MRI. Immediately after the prone MRI is completed, the patient will be repositioned for the supine MRI. Prior to starting the prone MRI, the study MRI technician/investigator will explain to the patient and practice with the patient the steps needed to transition from the prone to the supine MRI, so as to facilitate a timely transition. Additional MRI images will only take about 10-15 minutes to obtain and will not require a second injection of contrast material.', 'interventionNames': ['Other: Prone to Supine MRI']}], 'interventions': [{'name': 'Prone to Supine MRI', 'type': 'OTHER', 'description': 'The patient will be placed in the prone position and undergo a standard Gd contrast-enhanced bilateral breast MRI. Immediately after the prone MRI is completed, the patient will be repositioned for the supine MRI. Prior to starting the prone MRI, the study MRI technician/investigator will explain to the patient and practice with the patient the steps needed to transition from the prone to the supine MRI, so as to facilitate a timely transition. Additional MRI images will only take about 10-15 minutes to obtain and will not require a second injection of contrast material.', 'armGroupLabels': ['Prone to Supine MRI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03756', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Dartmouth Hitchcock Medical Center', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}], 'overallOfficials': [{'name': 'Timothy B Rooney, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dartmouth-Hitchcock Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dartmouth-Hitchcock Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Timothy B. Rooney', 'investigatorAffiliation': 'Dartmouth-Hitchcock Medical Center'}}}}