Pulmonary Interstitial Lymphography in Early Stage Lung Cancer

Summary

The stereotactic body radiation therapy (SBRT) procedure is an emerging alternative to the standard treatment for early stage non-small cell lung cancer (NSCLC), typically lobectomy with lymphadenectomy. This procedure (lobectomy) does not fulfill the medical need as many patients are poor operative candidates or decline surgery.

This study assesses the feasibility of stereotactic body radiation therapy (SBRT) as a tool to produce therapeutically useful computed tomography (CT) scans, using standard water-soluble iodinated compounds as the contrast agents.

Conditions

• Lung Cancer
• Lung Cancer Non-Small Cell Cancer (NSCLC)
• Lung Cancer Small Cell Lung Cancer (SCLC)
• Mesothelioma

Interventions

RADIATION

Stereotactic Body Radiation Therapy (SBRT)

Standard of care diagnostic radiotherapy procedure

RADIATION

Computed Tomography (CT)

For each participant, 3 chest CT scans will be obtained, 1 before and 2 after interstitial injection of the water-soluble contrast

DEVICE

Cyberknife

Linear accelerator for producing high energy x-rays for radiation therapy.

DEVICE

Trilogy

Linear accelerator for producing high energy x-rays for radiation therapy.

DEVICE

True Beam

Linear accelerator for producing high energy x-rays for radiation therapy.

DRUG

Iohexol

Aqueous solution of a nonionic, water-soluble radiographic contrast medium in prefilled cartridges with a molecular weight of 821.14 (iodine content 46.36%), available at 140, 180, 240, 300, and 350 mgI/mL.

DRUG

Iodixanol

Aqueous solution of a nonionic, water-soluble, dimeric, isosmolar, radiographic contrast medium with a molecular weight of 1550.20 (iodine content 49.1%), available in 2 concentrations, (270 mgI/mL and 320 mgI/mL.

Sponsors & Collaborators

• Stanford University

  lead OTHER

Principal Investigators

• Billy W Loo, Jr, MD, PhD · Stanford University

• Jonathan Abelson, MD · Stanford University

Study Design

Allocation

NA

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-08-31

Primary Completion

2017-04-30

Completion

2017-04-30

FDA Device

Yes

Countries

• United States

Study Locations