Lung NeoplasmNCT05046067
Feasibility Study of Anatomical Modeling for Image Guided Thoracic Surgery
A study testing Computed Tomography and Therapeutic Conventional Surgery in people with Lung Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This clinical trial assesses the feasibility of creating a 3 dimensional (D) model of the lung and lung nodule(s) from computed tomography (CT) scan images performed during lung surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Neoplasm
- What is being tested?
- Computed Tomography and Therapeutic Conventional Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2020to 19 Jul 2024
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have previous CT images demonstrating a lung mass or masses amenable to lung resection (open or minimally invasive)
- Patient is scheduled for surgical resection in a room equipped with intraoperative CT
- Patient must sign informed consent, with risks and benefits of CT imaging explained
- Patients with lung tumors >= 1cm to =< 3 cm based on preoperative CT scan. (Patients with lung tumors from < 1 cm or > 3 cm will be reviewed and approved for inclusion on an individual assessment by clinical collaborators)
Who cannot join
- Pediatric patients less than 18 years of age
- Patients who have undergone previous ipsilateral thoracic surgery, sclerotherapy, or radiation therapy as intraoperative adhesions may limit lung collapse intraoperatively
- Patients who received neoadjuvant immunotherapy
- Women who are pregnant or nursing
Trial locations and contacts
1 site in 1 country.
About this study
This clinical trial assesses the feasibility of creating a 3 dimensional (D) model of the lung and lung nodule(s) from computed tomography (CT) scan images performed during lung surgery. Unlike solid organs (like the kidney, brain, and liver), the lung changes shape (they inflate when a person breathe in and collapse when they breathe out). This makes it difficult to predict where, exactly, the tumor(s) will be on the lungs during surgery. A 3D model may help surgeons better predict where the location of the tumor(s) will be during surgery.
Read the detailed description
PRIMARY OBJECTIVE:
- To assess the feasibility of developing an anatomical model to predict the location of the tumor in a deflated lung to assist in guidance during lung surgery.
SECONDARY OBJECTIVES:
- Develop a registration technique to register the tumor onto the 2D/3D optical image obtained during surgery.
II. Determine the accuracy of mapping major segmental vasculature and bronchial structures onto 2D/3D optical images obtained during surgery.
OUTLINE:
Patients undergo 4 CT scans during standard of care surgery.
- Conditions
- Lung Neoplasm
- Being tested
- Computed Tomography, Therapeutic Conventional Surgery
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography
Undergo CT
Therapeutic Conventional SurgeryProcedure or surgery
Undergo surgery per standard of care
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (CT) | Experimental | Patients undergo 4 CT scans during standard of care surgery. Receives: Procedure: Computed Tomography; Procedure: Therapeutic Conventional Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of anatomical modeling for image guided thoracic surgery
The geometrical accuracy of the models for localizing the tumor will be quantified. The study is feasible if tumors for all 10 patients can be located with accuracy of within 1 cm or less. Anatomical modeling for image guided thoracic surgery will be considered feasible if researchers are able to determine the location of the tumor in a deflated lung to within the accuracy required by the surgeon for clinical use.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start16 Sep 2020
- Primary completion19 Jul 2024
- Study completion19 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NeoplasmStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ravi Rajaram, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05046067
- Sponsor's protocol ID
- 2019-1189
- Other IDs
- NCI-2021-06616, 2019-1189
- Status last verified
- Jul 2024
- First submitted
- 18 Jul 2021
- Last updated
- 28 Oct 2024
- 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 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Anatomical Modeling for Image Guided Thoracic Surgery
- ClinicalTrials.gov ID
- NCT05046067
- Acronym / sponsor ID
- 2019-1189
- Conditions
- Lung Neoplasm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 16 Sep 2020 (actual)
- Primary completion
- 19 Jul 2024 (actual)
- Study completion
- 19 Jul 2024 (actual)
- First posted
- 16 Sep 2021 (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.
This clinical trial assesses the feasibility of creating a 3 dimensional (D) model of the lung and lung nodule(s) from computed tomography (CT) scan images performed during lung surgery. Unlike solid organs (like the kidney, brain, and liver), the lung changes shape (they inflate when a person breathe in and collapse when they breathe out). This makes it difficult to predict where, exactly, the tumor(s) will be on the lungs during surgery. A 3D model may help surgeons better predict where the location of the tumor(s) will be during surgery.
Detailed description
PRIMARY OBJECTIVE:
- To assess the feasibility of developing an anatomical model to predict the location of the tumor in a deflated lung to assist in guidance during lung surgery.
SECONDARY OBJECTIVES:
- Develop a registration technique to register the tumor onto the 2D/3D optical image obtained during surgery.
II. Determine the accuracy of mapping major segmental vasculature and bronchial structures onto 2D/3D optical images obtained during surgery.
OUTLINE:
Patients undergo 4 CT scans during standard of care surgery.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (CT) | Experimental | Procedure: Computed Tomography, Procedure: Therapeutic Conventional SurgeryPatients undergo 4 CT scans during standard of care surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients must have previous CT images demonstrating a lung mass or masses amenable to lung resection (open or minimally invasive)
- Patient is scheduled for surgical resection in a room equipped with intraoperative CT
- Patient must sign informed consent, with risks and benefits of CT imaging explained
- Patients with lung tumors >= 1cm to =< 3 cm based on preoperative CT scan. (Patients with lung tumors from < 1 cm or > 3 cm will be reviewed and approved for inclusion on an individual assessment by clinical collaborators)
Key exclusion criteria (4 listed)
- Pediatric patients less than 18 years of age
- Patients who have undergone previous ipsilateral thoracic surgery, sclerotherapy, or radiation therapy as intraoperative adhesions may limit lung collapse intraoperatively
- Patients who received neoadjuvant immunotherapy
- Women who are pregnant or nursing
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 |
|---|---|---|
| Computed TomographyAlso: CAT, CAT Scan, Computerized Axial Tomography, Computerized TomographyUndergo CT | Procedure or surgery | Diagnostic (CT) |
| Therapeutic Conventional SurgeryUndergo surgery per standard of care | Procedure or surgery | Diagnostic (CT) |
Primary outcome
Feasibility of anatomical modeling for image guided thoracic surgery
Time frame: Up to 1 year
The geometrical accuracy of the models for localizing the tumor will be quantified. The study is feasible if tumors for all 10 patients can be located with accuracy of within 1 cm or less. Anatomical modeling for image guided thoracic surgery will be considered feasible if researchers are able to determine the location of the tumor in a deflated lung to within the accuracy required by the surgeon for clinical use.
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 28 Oct 2024.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Ravi Rajaram principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computed Tomography and Therapeutic Conventional Surgery in people with Lung Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
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 28 Oct 2024. 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 United States. 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?
Feasibility of anatomical modeling for image guided thoracic surgery (time frame: Up to 1 year). 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 28 Oct 2024.