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Feasibility Study of Anatomical Modeling for Image Guided Thoracic Surgery

M.D. Anderson Cancer Center logo

M.D. Anderson Cancer Center

Status

Completed

Conditions

Lung Neoplasm

Treatments

Procedure: Therapeutic Conventional Surgery
Procedure: Computed Tomography

Study type

Interventional

Funder types

Other

Identifiers

NCT05046067
NCI-2021-06616 (Registry Identifier)
2019-1189 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

3 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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)

Exclusion criteria

  • 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 design

Primary purpose

Health Services Research

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

3 participants in 1 patient group

Diagnostic (CT)
Experimental group
Description:
Patients undergo 4 CT scans during standard of care surgery.
Treatment:
Procedure: Computed Tomography
Procedure: Therapeutic Conventional Surgery

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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