Feasibility Study of Anatomical Modeling for Image Guided Thoracic Surgery

NCT05046067 | Completed

• 2 other identifiers: 2019-1189NCI-2021-06616
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Lung Neoplasm

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Diagnostic (CT)

EXPERIMENTAL

Patients undergo 4 CT scans during standard of care surgery.

Procedure: Computed Tomography; Procedure: Therapeutic Conventional Surgery

Interventions

Computed Tomography PROCEDURE

Undergo CT

Also known as: CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography, CT, CT Scan, tomography

Diagnostic (CT)

Therapeutic Conventional Surgery PROCEDURE

Undergo surgery per standard of care

Diagnostic (CT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Ravi Rajaram

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2021
• First Posted: September 16, 2021
• Study Start: September 16, 2020
• Primary Completion: July 19, 2024
• Study Completion: July 19, 2024
• Last Updated: October 28, 2024

Record last verified: 2024-07

Locations

US (1)