- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06600204
Comparison of SPECT/CT Perfusion and Volumetric CT Volume (VOLSEP)
Comparison of SPECT/CT Perfusion and Volumetric CT Volume to Predict Postoperative Pulmonary Function After Segmentectomy
Study Overview
Detailed Description
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.
Among 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Vandoeuvre/les/Nancy, France, 54511
- CHRU of Nancy
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Person having received full information on the organization of the research and not having opposed the exploitation of this data
- 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
- Patients having a complete pre-operative assessment (SPECT/CT, volumetric CT and EFR)
- Patients having 2 post-operative assessments (respiratory functional exploration (EFR) at approximately 1 month post-operatively and 6 months post-operatively).
Exclusion Criteria:
- Patients who underwent more extensive surgery (lobectomy, pneumectomy) or less extensive surgery (wedge).
- Patient who did not have a complete preoperative assessment (SPECT/CT or volumetric CT or missing respiratory functional exploration EFR).
- Patient who did not have a complete postoperative assessment (missing respiratory functional exploration EFR at 6 months).
NB: the absence of respiratory functional exploration EFR at 1 month postoperatively is not an exclusion criterion
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Patients who underwent a single or multiple segmentectomy
Patients who underwent a single or multiple segmentectomy in the thoracic surgery department of the Nancy University Hospital between April 2021 and July 2023
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Use the SPECT/CT to predict pulmonary function
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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.
Time Frame: 7 months
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Predicted postoperative pulmonary function using SPECT/CT (% perfusion participation of the removed segment(s)). Postoperative pulmonary function measured at 1 month Postoperative pulmonary function measured at 6 months |
7 months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2024PI070
- Retrospective study (Other Identifier: CHRU of NANCY)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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