Ignite Creation Date:
2025-12-25 @ 3:02 AM
Ignite Modification Date:
2025-12-26 @ 1:42 AM
Study NCT ID:
NCT07192133
Status:
RECRUITING
Last Update Posted:
2025-12-10
First Post:
2025-09-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of CT-XPI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014057', 'term': 'Tomography, X-Ray Computed'}], 'ancestors': [{'id': 'D007090', 'term': 'Image Interpretation, Computer-Assisted'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011856', 'term': 'Radiographic Image Enhancement'}, {'id': 'D007089', 'term': 'Image Enhancement'}, {'id': 'D010781', 'term': 'Photography'}, {'id': 'D011859', 'term': 'Radiography'}, {'id': 'D014056', 'term': 'Tomography, X-Ray'}, {'id': 'D014054', 'term': 'Tomography'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-09', 'studyFirstSubmitDate': '2025-09-17', 'studyFirstSubmitQcDate': '2025-09-17', 'lastUpdatePostDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lung x-ray pulsatility index (XPI)', 'timeFrame': '30 minutes', 'description': 'XPI, a representative of lung perfusion, will be measured using CT images. The dynamic x-ray attenuation from each pixel is analyzed using spectral analysis.'}, {'measure': 'Magnitude of XPI', 'timeFrame': '30 minutes', 'description': 'Measured as a number, this corresponds to the magnitude of the relative change of signal.'}, {'measure': 'Presence of XPI', 'timeFrame': '30 minutes', 'description': 'This will be evaluated quantitatively using CNR (contrast to noise) measurements which uses a region of interest in the lungs and a region of interest outside of the lungs.'}, {'measure': 'Spatial distribution of XPI signal', 'timeFrame': '30 minutes', 'description': 'This is a subjective evaluation, routinely done clinically with other modalities that measure lung perfusion. Researchers evaluate how homogenous (smooth) the signal is over the lungs and look for perfusion defects (areas with little or no XPI) which would indicate pathology.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['CT Scan', 'Computed Tomography']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if a new computed tomography (CT) lung perfusion imaging method is as effective as standard of care (SOC) CT imaging. The main question it aims to answer is:\n\n* Does the new contrast-free method provide more information about lung perfusion than SOC?\n\nParticipants will undergo a 30 minute chest CT.', 'detailedDescription': 'The purpose of the study is to evaluate X-ray Pulsatility Index using prospectively acquired dynamic CT, which is different from conventional static CT scans.\n\nThe primary objective of this study is to collect dynamic CT scan data with human participants using high frame rate imaging methods to produce a map of lung perfusion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or older\n* Able to sign and date the informed consent form\n* Will undergo a clinically-indicated CT exam of the head, neck, chest, abdomen, pelvis, or extremities\n\nExclusion Criteria:\n\n* Pregnant or lactating\n* In need of urgent or emergent care\n* Have any conditions that, in the opinion of the PI or designee, would interfere with the evaluation of the results or constitute a health hazard for the participant'}, 'identificationModule': {'nctId': 'NCT07192133', 'briefTitle': 'Evaluation of CT-XPI', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'Evaluation of Computed Tomography X-ray-Pulsatility Index (CT-XPI)', 'orgStudyIdInfo': {'id': '2025-0586'}, 'secondaryIdInfos': [{'id': 'SMPH/RADIOLOGY/RADIOLOGY', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'AS', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'Protocol Version 1/18/2025', 'type': 'OTHER', 'domain': 'UW Madison'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CT scan', 'description': 'Participants undergoing a CT', 'interventionNames': ['Diagnostic Test: CT scan']}], 'interventions': [{'name': 'CT scan', 'type': 'DIAGNOSTIC_TEST', 'description': 'Dynamic contrast-free chest CT scan', 'armGroupLabels': ['CT scan']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53705', 'city': 'Madison', 'state': 'Wisconsin', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Matthew Smith, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Timothy Szczykutowicz, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University of Wisconsin - Madison', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'centralContacts': [{'name': 'Radiology Studies', 'role': 'CONTACT', 'email': 'radstudy@uwhealth.org', 'phone': '608-282-8349'}], 'overallOfficials': [{'name': 'Matthew Smith, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin, Madison'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}