Lung Cancer (NSCLC)VOLSEPNCT06600204
Comparison of SPECT/CT Perfusion and Volumetric CT Volume
An observational study of Lung Cancer (NSCLC), run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Lung Cancer (NSCLC)
- What is being tested?
- lung scintigraphy
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 30 Nov 2024to 1 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Lung Cancer (NSCLC)
- Being tested
- lung scintigraphy
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lung scintigraphyOther
Use the SPECT/CT to predict pulmonary function
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: lung scintigraphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start30 Nov 2024
- Primary completion30 Apr 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antoine VERGER, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06600204
- Sponsor's protocol ID
- 2024PI070
- Other IDs
- Retrospective study
- Acronym
- VOLSEP
- Status last verified
- Jun 2025
- First submitted
- 13 Sep 2024
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of SPECT/CT Perfusion and Volumetric CT Volume to Predict Postoperative Pulmonary Function After Segmentectomy
- ClinicalTrials.gov ID
- NCT06600204
- Acronym / sponsor ID
- VOLSEP / 2024PI070
- Conditions
- Lung Cancer (NSCLC)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 30 Nov 2024 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who underwent a single or multiple segmentectomy | – | Other: lung scintigraphyPatients who underwent a single or multiple segmentectomy in the thoracic surgery department of the Nancy University Hospital between April 2021 and July 2023 |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lung scintigraphyUse the SPECT/CT to predict pulmonary function | Other | Patients who underwent a single or multiple segmentectomy |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer (NSCLC), run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2025.