Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:12 AM
Study NCT ID:
NCT04863027
Status:
COMPLETED
Last Update Posted:
2022-11-16
First Post:
2021-03-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Use of Dual Energy Computed Tomography in Thoracic Radiotherapy Planning.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D017564', 'term': 'Radiation Pneumonitis'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D055370', 'term': 'Lung Injury'}, {'id': 'D011832', 'term': 'Radiation Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-11', 'studyFirstSubmitDate': '2021-03-29', 'studyFirstSubmitQcDate': '2021-04-24', 'lastUpdatePostDateStruct': {'date': '2022-11-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lung function quantification at baseline', 'timeFrame': 'Baseline', 'description': 'To quantify lung function using perfusion DECT and use this information at the time of treatment planning with preferential sparing of functional lung parenchyma.'}, {'measure': 'Radiation-induced lung function damage quantification', 'timeFrame': 'at 12 months after radiotherapy', 'description': 'To evaluate lung function post-radiotherapy with both perfusion DECT and pulmonary function tests and compare radiation dose-map to functional lung-map.'}, {'measure': 'Radiation-induced lung function damage quantification', 'timeFrame': 'at 24 months after radiotherapy', 'description': 'To evaluate lung function post-radiotherapy with both perfusion DECT and pulmonary function tests and compare radiation dose-map to functional lung-map.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Cancer', 'Lung Function Decreased', 'Radiation Pneumonitis']}, 'descriptionModule': {'briefSummary': 'This is a prospective observational study aiming: 1) To quantify lung function using perfusion dual energy computed tomography (DECT) and use this information at the time of treatment planning with preferential sparing of functional lung parenchymal 2) to validate results of lung function obtained using DECT with lung perfusion scintigraphy results, the current standard method; 4) to compare dosimetry of whole lungs vs. functional lungs in patients treated with either stereotactic body radiotherapy (SBRT) for early stage lung cancer or conventional radiotherapy for locally advanced lung cancer and 5) to evaluate lung function 6, 12 and 24 months post-radiotherapy with both perfusion DECT and pulmonary function tests and compare radiation dose-map to functional lung-map.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with lung cancer planned for curative intent radiotherapy (conventional or stereotactic)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥ 18 years\n* ECOG 0-2\n* Pulmonary neoplasia, confirmed histopathologically or by imaging\n* Prognosis evaluated ≥ 1 year by attending MD\n* Clinically acceptable lung capacity to undergo radiotherapy\n* Initial assessment including history, physical examination, biochemistry, PFT, chest radiograph, chest and abdominal-pelvic scan, PET\n* Written consent\n* The patient must be available for treatment and monitoring. Patients registered in the study should be treated in our center.\n\nExclusion criteria\n\n* Previous radiotherapy in the radiation field\n* Presence of any major medical condition that, in the opinion of the investigator, would prevent follow-up at 6, 12 and 24 months post-radiotherapy.\n* Iodine allergy\n* Pregnancy and lactation'}, 'identificationModule': {'nctId': 'NCT04863027', 'briefTitle': 'Use of Dual Energy Computed Tomography in Thoracic Radiotherapy Planning.', 'organization': {'class': 'OTHER', 'fullName': "Centre hospitalier de l'Université de Montréal (CHUM)"}, 'officialTitle': 'PHASE I-II Study on the Use of Dual Energy Computed Tomography for Assessment of Lung Function in Thoracic Conventional and Stereotactic Body Radiotherapy', 'orgStudyIdInfo': {'id': '14.003'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Thoracic radiotherapy', 'type': 'RADIATION', 'description': 'Patients will have pre-treatment and post-treatment perfusion DECT for baseline and post-treatment lung function'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H2x 3E4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': "Centre Hospitalier de l'Université de Montréal", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Centre hospitalier de l'Université de Montréal (CHUM)", 'class': 'OTHER'}, 'collaborators': [{'name': 'Varian Medical Systems', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}