Comparison of SPECT/CT Perfusion and Volumetric CT Volume (VOLSEP)

June 4, 2025 updated by: Antoine VERGER, Central Hospital, Nancy, France

Comparison of SPECT/CT Perfusion and Volumetric CT Volume to Predict Postoperative Pulmonary Function After Segmentectomy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Vandoeuvre/les/Nancy, France, 54511
        • CHRU of Nancy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Retrospective study including patients who underwent preoperative SPECT/CT pulmonary perfusion scintigraphy examination in the nuclear medicine department, from April 2021 to June 2023.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Use the SPECT/CT to predict pulmonary function

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2024

Primary Completion (Actual)

April 30, 2025

Study Completion (Actual)

June 1, 2025

Study Registration Dates

First Submitted

September 13, 2024

First Submitted That Met QC Criteria

September 13, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

June 6, 2025

Last Update Submitted That Met QC Criteria

June 4, 2025

Last Verified

June 1, 2025

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

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe