Ignite Creation Date:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2026-02-26 @ 12:04 PM
Study NCT ID:
NCT01706705
Status:
COMPLETED
Last Update Posted:
2022-02-23
First Post:
2012-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Magnetic Resonance Imaging (MRI) Brachytherapy Applicator Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'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'}]}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'aklopp@mdanderson.org', 'phone': '713-563-6930', 'title': 'Dr. Ann Klopp / Associate Professor, Radiation Oncology', 'organization': 'UT MD Anderson Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'At the time of implant', 'eventGroups': [{'id': 'EG000', 'title': 'Experimental Brachytherapy Treatment Planning', 'description': 'Single Arm study in which eligible patients were women with a diagnosis of 1B2cervical cancer with definitive chemoradiation or radiation therapy who required brachytherapy.', 'otherNumAtRisk': 37, 'deathsNumAtRisk': 37, 'otherNumAffected': 0, 'seriousNumAtRisk': 37, 'deathsNumAffected': 1, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Improved Image Quality in the Shifted Position', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Brachytherapy Treatment Planning', 'description': 'Single Arm in which eligible patients were women with a diagnosis of 1B2cervical cancer with definitive chemoradiation or radiation therapy who required brachytherapy.'}], 'classes': [{'title': 'Standard Position', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Shifted Position', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At the time of implant', 'description': 'To determine the number of participants with improved image quality using the Novel Brachytherapy Applicator, using subjective and objective measures. In the subjective, for assessment of image quality for clinical use, the images obtained in the "shifted" position and in the "standard" position, were compared by a radiation oncologist without knowledge of which was the first and which was the second image. To provide and objective measure of the reduction in image artifact with the shields shifted, the bladder, rectum, and sigmoid were contoured, and average and standard deviation of Hounsfield units (HU) within these critical structures on the images were compared.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With High Quality Images With the Adaptive Applicator in the Shifted or Standard Position', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm-Study', 'description': 'Experimental Brachytherapy Treatment Planning'}], 'classes': [{'title': 'Adaptive Applicator in the Standard Position', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Adaptive Applicator in the Shifted Position', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At the time of implant', 'description': 'The number of participants with high quality images of the bladder, rectum and sigmoid with the adaptive applicator in the shifted position and standard position assessed by the Hounsfield unit values. The higher quality images are the images with higher density when the applicator is in either the shifted or standard position. The Hounsfield unit (HU) is a relative quantitative measurement of radio density used by radiologists in the interpretation of computed tomography (CT) images. The images obtained in the "shifted" position and in the "standard" position with the use of the adaptive applicator, were compared by a radiation oncologist without knowledge of which was the first and which was the second image.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The adaptive applicator fit into 15 of the evaluated patients so the analysis was limited to these 15 patients.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': '3D Image-guided Intracavitary Brachytherapy Treatment Planning in Cervical Cancer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm-Study', 'description': 'Experimental Brachytherapy Treatment Planning'}], 'timeFrame': '24 months from baseline', 'description': 'Analysis was conducted using JMP Pro statistical software for patients diagnosis of 1B2cervical cancer', 'reportingStatus': 'POSTED', 'populationDescription': 'No data collected'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Magnetic Resonance Imaging (MRI) is Superior to Computed Tomography (CT) Imaging in Delineating a High Risk Target Volume. 3D Image-guided Intracavitary Brachytherapy Treatment Planning in Cervical Cancer".', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm-Study', 'description': 'Experimental Brachytherapy Treatment Planning'}], 'timeFrame': '24 months from baseline ( 2-years)', 'description': 'Utility of MRI imaging as compared to CT or MRI can improve dosimetric tumor coverage and normal tissue sparing.', 'reportingStatus': 'POSTED', 'populationDescription': 'No data collected'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Clinical and Tumor Characteristics of Patients in Whom CT or MRI Can Improve Dosimetric Tumor Coverage and Normal Tissue Sparing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm-Study', 'description': 'Experimental Brachytherapy Treatment Planning'}], 'timeFrame': '24 months from baseline ( 2-years)', 'description': 'MRI-based brachytherapy planning for patients with tumors \\>5 cm and parametrial invasion on MRI at diagnosis and for those with a high BMI', 'reportingStatus': 'POSTED', 'populationDescription': 'No data collected'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Feasibility of MRI-based Treatment Planning Utilizing the Shielded MD Anderson Adaptive Applicator.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm-Study', 'description': 'Experimental Brachytherapy Treatment Planning'}], 'timeFrame': '24 months from baseline ( 2-years)', 'description': 'RI-adaptive applicators for treatment planning for every case/patient.', 'reportingStatus': 'POSTED', 'populationDescription': 'No data collected'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Relative Resource Utilization for MRI and CT Based Treatment Planning as Compared to Standard Film Based Planning Techniques.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm-Study', 'description': 'Experimental Brachytherapy Treatment Planning'}], 'timeFrame': 'Not able to complete', 'description': 'Due to lack of a suitable comparison population during this timeframe- at our institution, these protocol-eligible cervical cancer patients were no longer undergoing brachytherapy treatment planning based solely off standard plain films alone.', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to lack of a suitable comparison population during this timeframe- at our institution, these protocol-eligible cervical cancer patients were no longer undergoing brachytherapy treatment planning based solely off standard plain films alone.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Experimental Brachytherapy Treatment Planning', 'description': 'Single Arm in which eligible patients were women with a diagnosis of 1B2cervical cancer with definitive chemoradiation or radiation therapy who required brachytherapy.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'Non-clinical', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Experimental Brachytherapy Treatment Planning', 'description': 'Single Arm in which eligible patients were women with a diagnosis of 1B2cervical cancer with definitive chemoradiation or radiation therapy who required brachytherapy.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '35', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000', 'lowerLimit': '25', 'upperLimit': '94'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '37', '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': '10', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', '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': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '34', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2014-05-05', 'size': 254614, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-04-24T10:54', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2018-04-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-31', 'studyFirstSubmitDate': '2012-10-11', 'resultsFirstSubmitDate': '2019-09-03', 'studyFirstSubmitQcDate': '2012-10-11', 'lastUpdatePostDateStruct': {'date': '2022-02-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-01-31', 'studyFirstPostDateStruct': {'date': '2012-10-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': '3D Image-guided Intracavitary Brachytherapy Treatment Planning in Cervical Cancer', 'timeFrame': '24 months from baseline', 'description': 'Analysis was conducted using JMP Pro statistical software for patients diagnosis of 1B2cervical cancer'}, {'measure': 'Magnetic Resonance Imaging (MRI) is Superior to Computed Tomography (CT) Imaging in Delineating a High Risk Target Volume. 3D Image-guided Intracavitary Brachytherapy Treatment Planning in Cervical Cancer".', 'timeFrame': '24 months from baseline ( 2-years)', 'description': 'Utility of MRI imaging as compared to CT or MRI can improve dosimetric tumor coverage and normal tissue sparing.'}, {'measure': 'Clinical and Tumor Characteristics of Patients in Whom CT or MRI Can Improve Dosimetric Tumor Coverage and Normal Tissue Sparing', 'timeFrame': '24 months from baseline ( 2-years)', 'description': 'MRI-based brachytherapy planning for patients with tumors \\>5 cm and parametrial invasion on MRI at diagnosis and for those with a high BMI'}, {'measure': 'Feasibility of MRI-based Treatment Planning Utilizing the Shielded MD Anderson Adaptive Applicator.', 'timeFrame': '24 months from baseline ( 2-years)', 'description': 'RI-adaptive applicators for treatment planning for every case/patient.'}, {'measure': 'Relative Resource Utilization for MRI and CT Based Treatment Planning as Compared to Standard Film Based Planning Techniques.', 'timeFrame': 'Not able to complete', 'description': 'Due to lack of a suitable comparison population during this timeframe- at our institution, these protocol-eligible cervical cancer patients were no longer undergoing brachytherapy treatment planning based solely off standard plain films alone.'}], 'primaryOutcomes': [{'measure': 'Number of Participants With Improved Image Quality in the Shifted Position', 'timeFrame': 'At the time of implant', 'description': 'To determine the number of participants with improved image quality using the Novel Brachytherapy Applicator, using subjective and objective measures. In the subjective, for assessment of image quality for clinical use, the images obtained in the "shifted" position and in the "standard" position, were compared by a radiation oncologist without knowledge of which was the first and which was the second image. To provide and objective measure of the reduction in image artifact with the shields shifted, the bladder, rectum, and sigmoid were contoured, and average and standard deviation of Hounsfield units (HU) within these critical structures on the images were compared.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With High Quality Images With the Adaptive Applicator in the Shifted or Standard Position', 'timeFrame': 'At the time of implant', 'description': 'The number of participants with high quality images of the bladder, rectum and sigmoid with the adaptive applicator in the shifted position and standard position assessed by the Hounsfield unit values. The higher quality images are the images with higher density when the applicator is in either the shifted or standard position. The Hounsfield unit (HU) is a relative quantitative measurement of radio density used by radiologists in the interpretation of computed tomography (CT) images. The images obtained in the "shifted" position and in the "standard" position with the use of the adaptive applicator, were compared by a radiation oncologist without knowledge of which was the first and which was the second image.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cervical Cancer', 'Radiation therapy', 'XRT', 'External beam therapy', 'Brachytherapy', 'Intracavitary brachytherapy', 'ICBT', 'MRI compatible intracavitary applicators', 'Computed tomography', 'CT', 'Magnetic resonance imaging', 'MRI', 'MRI compatible applicators', '3D image guided treatment planning', '2D treatment planning'], 'conditions': ['Cervical Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'University of Texas MD Anderson Cancer Center Website'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical research study is to learn if computed tomography (CT) and magnetic resonance imaging (MRI) images can better help to plan internal radiation treatment.', 'detailedDescription': 'Treatment planning for patients with cervical cancer treated at MD Anderson is usually performed based on x-ray films taken while the patient is under anesthesia in the operating room. In this study, you will have an MRI and CT scan performed after recovering from anesthesia in addition to the standard x-rays. In order to allow MRI images to be taken, special MRI compatible applicators will be used. The CT and MRI images will be reviewed by the doctor in charge of radiation treatment and will also be used for research purposes.\n\nStudy Procedures:\n\nIf you agree to take part in this study, an applicator made of a material that can be used during an MRI will be used.\n\nYou will have a CT scan and an MRI scan performed after the implant is placed in the operating room. The CT scan should take about 20 minutes and the MRI about 55 minutes. These scans will be performed after you wake up from general anesthesia. Pain medicine will be given if you feel any discomfort from the placement of the implant.\n\nThe additional scans will be used to confirm appropriate placement of the applicator and may result in small adjustments to your radiation treatment plan.\n\nLength of Study:\n\nYour active participation on this study will be complete once you have the CT and MRI scans.\n\nYour medical record may be reviewed after the scans for the purposes of the study, but you will not be contacted in the future.\n\nThis is an investigational study. The applicator that best fits your personal anatomy will be used in this study. A selection of MRI compatible applicators are available. Many of the MRI applicators that will be used are FDA approved. However, in some cases you may have a novel device with a moveable shield placed. This applicator is not FDA approved or commercially available.\n\nUp to 57 patients will take part in this study. All will be enrolled at MD Anderson.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\) Women with stage greater than or equal to IB2 cervical cancer treated with definitive chemoradiation or radiation therapy who require intracavitary brachytherapy.\n\nExclusion Criteria:\n\n1. Patient or tumor anatomy that requires use of a non-MRI-compatible applicator.\n2. Patients who require interstitial brachytherapy.\n3. Patients whose treating physician feels that they require additional 3D imaging at the time of implant based on physical exam or initial findings.\n4. Patients with implantable cardioverter-defibrillator, pacemaker or other implanted device, which precludes MRI acquisition.'}, 'identificationModule': {'nctId': 'NCT01706705', 'briefTitle': 'Magnetic Resonance Imaging (MRI) Brachytherapy Applicator Study', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': '3D Image-guided Intracavitary Brachytherapy Treatment Planning for Cervical Cancer Using a Novel Shielded Applicator', 'orgStudyIdInfo': {'id': '2012-0546'}, 'secondaryIdInfos': [{'id': 'NCI-2012-02120', 'type': 'REGISTRY', 'domain': 'NCI CTRP'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Brachytherapy Treatment Planning', 'description': "MRI-compatible intracavitary applicator inserted using ultrasound guidance to verify tandem placement in the uterus. Tandem and ovoids, tandem and cylinders, or tandem and ring chosen to accommodate patient's tumor and vaginal anatomy.\n\nComputed tomography (CT) scan and a magnetic resonance imaging (MRI) scan performed after the implant is placed in the operating room. The CT scan should take about 20 minutes and the MRI about 45 minutes.", 'interventionNames': ['Device: Intracavitary Applicator Placement', 'Other: Computed Tomography (CT)', 'Other: Magnetic Resonance Imaging (MRI)']}], 'interventions': [{'name': 'Intracavitary Applicator Placement', 'type': 'DEVICE', 'otherNames': ['MDA Applicator'], 'description': "MRI-compatible applicator inserted using ultrasound guidance to verify tandem placement in the uterus. Tandem and ovoids, tandem and cylinders, or tandem and ring chosen to accommodate patient's tumor and vaginal anatomy.", 'armGroupLabels': ['Brachytherapy Treatment Planning']}, {'name': 'Computed Tomography (CT)', 'type': 'OTHER', 'otherNames': ['CT'], 'description': 'CT scan performed after implant is placed in operating room. CT scan should take about 20 minutes.', 'armGroupLabels': ['Brachytherapy Treatment Planning']}, {'name': 'Magnetic Resonance Imaging (MRI)', 'type': 'OTHER', 'otherNames': ['MRI'], 'description': 'MRI scan performed after implant is placed in the operating room. MRI should take about 45 minutes.', 'armGroupLabels': ['Brachytherapy Treatment Planning']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Ann Klopp, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}