Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2025-12-26 @ 1:06 AM
Study NCT ID:
NCT07219134
Status:
RECRUITING
Last Update Posted:
2025-10-21
First Post:
2025-08-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pilot Investigation of Dual Energy CT Imaging on an Online Adaptive Radiation Therapy System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010386', 'term': 'Pelvic Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-16', 'studyFirstSubmitDate': '2025-08-11', 'studyFirstSubmitQcDate': '2025-10-16', 'lastUpdatePostDateStruct': {'date': '2025-10-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Image quality- Mean', 'timeFrame': 'Up to 2 years', 'description': 'The primary analysis will compare imaging quality endpoints processed by DE-CBCT and the standard of care SE-CBCT, with the latter representing the standard clinical acquisition. Descriptive statistics will be computed for the image quality metrics from each imaging modality and for the difference in metrics between the modalities. A paired t-test or Wilcoxon signed-rank test will compare the distribution of the image quality metrics between DE-CBCT and standard of care SE-CBCT. Secondary analysis will compare image quality endpoints between DE-CBCT and standard of care conventional planning CT.'}, {'measure': 'Image quality- median', 'timeFrame': 'Up to 2 years', 'description': 'The primary analysis will compare imaging quality endpoints processed by DE-CBCT and the standard of care SE-CBCT, with the latter representing the standard clinical acquisition. Descriptive statistics will be computed for the image quality metrics from each imaging modality and for the difference in metrics between the modalities. A paired t-test or Wilcoxon signed-rank test will compare the distribution of the image quality metrics between DE-CBCT and standard of care SE-CBCT. Secondary analysis will compare image quality endpoints between DE-CBCT and standard of care conventional planning CT.'}]}, 'conditionsModule': {'conditions': ['Genitourinary System Carcinoma', 'Malignant Pelvic Neoplasm']}, 'descriptionModule': {'briefSummary': "This study is being done to see if researchers can find a better way to image a patient's tumor during radiation treatment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with pelvis or genitourinary cancer requiring standard of care radiotherapy treatment', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\* Patients with pelvis or genitourinary (GU) cancer requiring standard of care radiotherapy treatment\n\n * All adults, defined as individuals of 18 years of age or greater\n * Radiotherapy treatment will be performed on the Varian Ethos radiotherapy system\n * Ability to understand and the willingness to sign a written informed consent\n\nExclusion Criteria:\n\n* \\* Minors, defined as individuals less than 18 years of age\n\n * Pregnant or nursing female'}, 'identificationModule': {'nctId': 'NCT07219134', 'briefTitle': 'Pilot Investigation of Dual Energy CT Imaging on an Online Adaptive Radiation Therapy System', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan Rogel Cancer Center'}, 'officialTitle': 'Pilot Investigation of Dual Energy CT Imaging on an Online Adaptive Radiation Therapy System', 'orgStudyIdInfo': {'id': 'UMCC 2024.027'}, 'secondaryIdInfos': [{'id': 'NCI-2025-03767', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'HUM00259510', 'type': 'OTHER', 'domain': 'University of Michigan'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observational', 'description': 'Patients undergo lower beam energy CBCT scan once during standard of care radiation therapy on study.', 'interventionNames': ['Other: Non-Interventional Study']}], 'interventions': [{'name': 'Non-Interventional Study', 'type': 'OTHER', 'description': 'Non-interventional study', 'armGroupLabels': ['Observational']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Cancer AnswerLine', 'role': 'CONTACT', 'email': 'CancerAnswerLine@med.umich.edu', 'phone': '800-865-1125'}, {'name': 'Robert Dess', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Michigan Comprehensive Cancer Center', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'centralContacts': [{'name': 'Cancer AnswerLine', 'role': 'CONTACT', 'email': 'CancerAnswerLine@med.umich.edu', 'phone': '1-800-865-1125'}], 'overallOfficials': [{'name': 'Robert Dess', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan Rogel Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan Rogel Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Varian Medical Systems, Inc.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}