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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-06616 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2019-1189 | Other Identifier | M D Anderson Cancer Center |
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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.
PRIMARY OBJECTIVE:
I. 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:
I. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (CT) | Experimental | Patients undergo 4 CT scans during standard of care surgery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computed Tomography | Procedure | Undergo CT |
|
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ravi Rajaram | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center Website | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Nov 29, 2023 | Oct 24, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Therapeutic Conventional Surgery | Procedure | Undergo surgery per standard of care |
|
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |