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Clinical Trials/NCT01188486
NCT01188486
Terminated
Not Applicable

Pulmonary Interstitial Lymphography in Early Stage Lung Cancer

Stanford University1 site in 1 country12 target enrollmentStarted: August 2010Last updated:

Overview

Phase
Not Applicable
Status
Terminated
Enrollment
12
Locations
1
Primary Endpoint
- Feasibility and safety of identification of primary nodal drainage for purpose of radiation therapy targeting

Overview

Brief 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.

Detailed Description

Non-small cell lung cancer (NSCLC) is the most deadly cancer in the world. NSCLC annually causes 150,000 deaths in the US and greater than 1 million worldwide. The standard treatment for early stage NSCLC is lobectomy with lymphadenectomy. However, many patients are poor operative candidates or decline surgery. An emerging alternative is Stereotactic Body Radiation Therapy (SBRT). Mounting evidence from phase 1-2 studies demonstrates that SBRT offers excellent local control. Most SBRT trials focused on small, peripheral tumors in inoperable patients. Increasingly, clinical trials study SBRT in operable patients, often with larger, central tumors.

Using clinical staging, a significant proportion of patients harbor occult nodal metastases when undergoing SBRT to the primary tumor alone. Subgroups of patients carry even higher risk of nodal metastases. These nodal metastases frequently would be removed by surgical intervention. However, SBRT, at present, is only directed at the primary tumor, potentially leading to regional failures in otherwise curable patients. To increase the effectiveness of SBRT for lung tumors, the next logical step is to explore whether the highest risk areas of disease spread can be identified and targeted. Regional failure could be reduced and outcome improved in a significant proportion of patients treated with SBRT if the primary nodal drainage (PND) were identified, targeted and treated in addition to the primary tumor.

We propose to conduct a study to determine the feasibility of visualizing, by computed tomography (CT) scans, water-soluble iodinated contrast materials after direct injection into the tumor. Integration into radiation therapy treatment planning may also be assessed.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Device Feasibility
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

pulmonary interstitial lymphography

Experimental

stereotactic body radiation therapy & pulmonary interstitial lymphography

Intervention: Stereotactic Body Radiation Therapy (SBRT) (Radiation)

pulmonary interstitial lymphography

Experimental

stereotactic body radiation therapy & pulmonary interstitial lymphography

Intervention: Computed Tomography (CT) (Radiation)

pulmonary interstitial lymphography

Experimental

stereotactic body radiation therapy & pulmonary interstitial lymphography

Intervention: Cyberknife (Device)

pulmonary interstitial lymphography

Experimental

stereotactic body radiation therapy & pulmonary interstitial lymphography

Intervention: Trilogy (Device)

pulmonary interstitial lymphography

Experimental

stereotactic body radiation therapy & pulmonary interstitial lymphography

Intervention: True Beam (Device)

pulmonary interstitial lymphography

Experimental

stereotactic body radiation therapy & pulmonary interstitial lymphography

Intervention: Iohexol (Drug)

pulmonary interstitial lymphography

Experimental

stereotactic body radiation therapy & pulmonary interstitial lymphography

Intervention: Iodixanol (Drug)

Outcomes

Primary Outcomes

- Feasibility and safety of identification of primary nodal drainage for purpose of radiation therapy targeting

Time Frame: 15 months

Secondary Outcomes

  • - Feasibility of incorporating primary nodal drainage into radiation therapy planning process(15 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Billy W. Loo Jr.

Associate Professor of Radiation Oncology

Stanford University

Study Sites (1)

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