Feasibility Study of Anatomical Modeling for Image Guided Thoracic Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-16

Study Completion Date

2024-07-19

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Lung Neoplasm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Diagnostic (CT)

Patients undergo 4 CT scans during standard of care surgery.

Group Type EXPERIMENTAL

Computed Tomography

Intervention Type PROCEDURE

Undergo CT

Therapeutic Conventional Surgery

Intervention Type PROCEDURE

Undergo surgery per standard of care

Interventions

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Computed Tomography

Undergo CT

Intervention Type PROCEDURE

Therapeutic Conventional Surgery

Undergo surgery per standard of care

Intervention Type PROCEDURE

Other Intervention Names

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CAT CAT Scan Computerized Axial Tomography Computerized Tomography CT CT Scan tomography

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No