Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2026-01-05 @ 5:23 PM
Study NCT ID:
NCT06600204
Status:
COMPLETED
Last Update Posted:
2025-06-06
First Post:
2024-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of SPECT/CT Perfusion and Volumetric CT Volume
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], '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': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-11-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-04', 'studyFirstSubmitDate': '2024-09-13', 'studyFirstSubmitQcDate': '2024-09-13', 'lastUpdatePostDateStruct': {'date': '2025-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To demonstrate that SPECT/CT is a reliable examination for predicting postoperative pulmonary function after segmentectomy, by comparing this predicted function to that measured at 1 and 6 months.', 'timeFrame': '7 months', 'description': 'Predicted postoperative pulmonary function using SPECT/CT (% perfusion participation of the removed segment(s)).\n\nPostoperative pulmonary function measured at 1 month Postoperative pulmonary function measured at 6 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Cancer (NSCLC)']}, 'descriptionModule': {'briefSummary': 'The main aim of this study is to show that single photon emission tomography/Computer tomography (SPECT/CT) is a reliable examination to predict postoperative pulmonary function after segmentectomy, by comparing this predicted function to that measured at 1 and 6 months.', 'detailedDescription': 'Lung cancer has a high prevalence, incidence and mortality in France and worldwide. Surgical treatment, possible only at an early stage, improves the prognosis of patients. In addition, the increasing accessibility of chest CT scans allows early detection and monitoring of small pulmonary nodules. As a result, more conservative surgical techniques are becoming increasingly important, including segmentectomy.\n\nAmong patients for whom it is indicated, the preoperative assessment involves the evaluation of pulmonary function and the prediction of postoperative pulmonary function in order to validate the feasibility of surgery. To do this, several methods have been described: anatomical methods (segment counting), radiological imaging methods (CT, DECT, perfusion MRI), and nuclear imaging methods (planar perfusion and/or ventilation pulmonary scintigraphy, SPECT pulmonary perfusion scintigraphy), some of which are hybrid (SPECT/CT). The use of SPECT/CT to predict postoperative pulmonary function is routinely practiced, and its reliability, accuracy, and concordance with measured postoperative pulmonary function are well demonstrated for pneumectomy and lobectomy. For more conservative surgeries, the data in the literature remain uncertain. However, being able to predict pulmonary function is essential, both to justify the feasibility of the intervention, but also to target the most fragile patients and intensify their postoperative respiratory rehabilitation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Retrospective study including patients who underwent preoperative SPECT/CT pulmonary perfusion scintigraphy examination in the nuclear medicine department, from April 2021 to June 2023.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Person having received full information on the organization of the research and not having opposed the exploitation of this data\n* Patients having benefited from a single or multiple segmentectomy within the thoracic surgery department of the CHRU of Nancy during the period April 2021 to June 2023\n* Patients having a complete pre-operative assessment (SPECT/CT, volumetric CT and EFR)\n* Patients having 2 post-operative assessments (respiratory functional exploration (EFR) at approximately 1 month post-operatively and 6 months post-operatively).\n\nExclusion Criteria:\n\n* Patients who underwent more extensive surgery (lobectomy, pneumectomy) or less extensive surgery (wedge).\n* Patient who did not have a complete preoperative assessment (SPECT/CT or volumetric CT or missing respiratory functional exploration EFR).\n* Patient who did not have a complete postoperative assessment (missing respiratory functional exploration EFR at 6 months).\n\nNB: the absence of respiratory functional exploration EFR at 1 month postoperatively is not an exclusion criterion'}, 'identificationModule': {'nctId': 'NCT06600204', 'acronym': 'VOLSEP', 'briefTitle': 'Comparison of SPECT/CT Perfusion and Volumetric CT Volume', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Comparison of SPECT/CT Perfusion and Volumetric CT Volume to Predict Postoperative Pulmonary Function After Segmentectomy', 'orgStudyIdInfo': {'id': '2024PI070'}, 'secondaryIdInfos': [{'id': 'Retrospective study', 'type': 'OTHER', 'domain': 'CHRU of NANCY'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients who underwent a single or multiple segmentectomy', 'description': 'Patients who underwent a single or multiple segmentectomy in the thoracic surgery department of the Nancy University Hospital between April 2021 and July 2023', 'interventionNames': ['Other: lung scintigraphy']}], 'interventions': [{'name': 'lung scintigraphy', 'type': 'OTHER', 'description': 'Use the SPECT/CT to predict pulmonary function', 'armGroupLabels': ['Patients who underwent a single or multiple segmentectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54511', 'city': 'Vandœuvre-lès-Nancy', 'country': 'France', 'facility': 'CHRU of NANCY', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Antoine VERGER', 'investigatorAffiliation': 'Central Hospital, Nancy, France'}}}}