Ignite Creation Date:
2025-12-24 @ 10:15 PM
Ignite Modification Date:
2026-02-06 @ 6:11 AM
Study NCT ID:
NCT05054335
Status:
RECRUITING
Last Update Posted:
2025-11-18
First Post:
2019-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient-Specific Computational Walking Models in Improving Surgical and Rehabilitation Treatment in Patients With Pelvic Sarcomas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014965', 'term': 'X-Rays'}], 'ancestors': [{'id': 'D060733', 'term': 'Electromagnetic Radiation'}, {'id': 'D055590', 'term': 'Electromagnetic Phenomena'}, {'id': 'D060328', 'term': 'Magnetic Phenomena'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D011839', 'term': 'Radiation, Ionizing'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 130}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-12-21', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2019-03-07', 'studyFirstSubmitQcDate': '2021-09-16', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-09-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To establish the patient-specific computational models to inform surgical decisions and design custom implants that maximize post-surgery function.', 'timeFrame': 'through study completion, an average of 1 year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pelvic Sarcoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'M D Anderson Cancer Center'}]}, 'descriptionModule': {'briefSummary': "This trial studies the development of patient-specific computational walking models to improve the surgical planning and rehabilitation treatment of patients with pelvic sarcomas. Every pelvis and pelvic sarcoma are different, and the orthopedic oncologist faces significant challenges when removing a tumor from the complex anatomy of the pelvis. These challenges make it difficult to achieve excellent oncological and functional outcomes together. Computational walking models may be used to predict the best combination of surgical methods and how to implement them to maximize each patient's post-surgery walking function.", 'detailedDescription': "PRIMARY OBJECTIVES:\n\nI. To develop patient-specific computational walking models to predict the optimal combination of pelvic sarcoma surgical and rehabilitation decisions that will maximize each patient's post-surgery walking function.\n\nII. To collect experimental movement and imaging data prospectively and retrospectively from individuals who have already received, or are going to receive, a type I or type II hemipelvectomy.\n\nIII. To use the data to develop computational modeling and simulation methodologies that can predict an individual patient's post-surgery walking function given pre-surgery movement and imaging data and the surgical decisions made by the surgeon.\n\nOUTLINE:\n\nPatients undergo walking function assessment using optical motion capture and bi-plane dynamic X-ray imaging pre- and post-hemipelvectomy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients who have received or are scheduled to receive an internal hemipelvectomy with or without reconstruction at UT MD Anderson Cancer Center.\n2. Patients who are 18 years of age and older\n\nExclusion Criteria:\n\n1. Patients who have undergone an external (hindquarter amputated), or an isolated type III internal hemipelvectomy.\n2. Previous surgery or significant injury to either hip (prospective patients only)\n3. Relevant surgery, procedure, injury, or condition in the last two years which may affect hip pain or general movement patterns on either side (prospective patients only)\n4. Pregnant women or women nursing an infant\n5. Persons with a pacemaker, hearing aid, aneurysm clips or artificial heart valves, and other forms of loose metal implants will be excluded from the study as assessed by a pre-MRI questionnaire administered by the MRI technician at the time of the scan.\n6. Radiological exclusion criteria (assessed after MR scan is conducted on the first visit, prior to DSX/CT radiation exposure): evidence on preliminary MRI of fracture, slipped capital femoral epiphysis (SCFE), masses, lesions, or other anomalies not consistent with an FAI diagnosis.'}, 'identificationModule': {'nctId': 'NCT05054335', 'briefTitle': 'Patient-Specific Computational Walking Models in Improving Surgical and Rehabilitation Treatment in Patients With Pelvic Sarcomas', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'CPRIT: Optimizing Surgical and Rehabilitation Treatment of Pelvic Sarcomas Using Computational Models', 'orgStudyIdInfo': {'id': '2018-0216'}, 'secondaryIdInfos': [{'id': 'NCI-2019-00862', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '2018-0216', 'type': 'OTHER', 'domain': 'M D Anderson Cancer Center'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Supportive care (walking function test, X-ray)', 'description': 'Patients undergo walking function assessment using optical motion capture and bi-plane dynamic X-ray imaging pre- and post-hemipelvectomy.', 'interventionNames': ['Other: Functional Assessment', 'Procedure: X-Ray Imaging']}, {'type': 'NO_INTERVENTION', 'label': 'Retrospective Group', 'description': '1. Acquisition of pre- and post-operative MRI data of the pelvic region (when available) collected previously as part of standard clinical care\n2. Acquisition of pre-operative CT data of the pelvic region (when available) collected previously as part of standard clinical care\n3. Acquisition of Physical Therapy Assessment data collected previously by a physical therapist and/or physical therapist assistant under protocol PA12-1046'}], 'interventions': [{'name': 'Functional Assessment', 'type': 'OTHER', 'description': 'Undergo walking function assessment with optical motion capture', 'armGroupLabels': ['Supportive care (walking function test, X-ray)']}, {'name': 'X-Ray Imaging', 'type': 'PROCEDURE', 'otherNames': ['Conventional X-Ray', 'Diagnostic Radiology', 'Medical Imaging, X-Ray', 'Radiography', 'Static X-Ray', 'X-Ray'], 'description': 'Undergo bi-plane dynamic X-ray imaging', 'armGroupLabels': ['Supportive care (walking function test, X-ray)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Valerae O. Lewis', 'role': 'CONTACT', 'email': 'volewis@mdanderson.org', 'phone': '713-745-4117'}, {'name': 'Valerae O. Lewis', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'M D Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Valerae O Lewis, BS,MD', 'role': 'CONTACT', 'email': 'volewis@mdanderson.org', 'phone': '(713) 792-5073'}], 'overallOfficials': [{'name': 'Valerae O Lewis', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}