Pulmonary Interstitial Lymphography in Early Stage Lung Cancer
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 I/II 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 how well water soluble iodinated contrast material when injected directly into the tumor can be visualized on CT scan and integrated into radiation therapy treatment planning.
|Lung Cancer Lung Cancer Non-Small Cell Cancer (NSCLC) Lung Cancer Small Cell Lung Cancer (SCLC) Mesothelioma||Procedure: Stereotactic Body Radiation Therapy (SBRT) Drug: Iohexol Radiation: Computed Tomography (CT) Device: Cyberknife Device: Trilogy Device: True Beam|
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Diagnostic
|Official Title:||Pulmonary Interstitial Lymphography in Early Stage Lung Cancer|
- - Feasibility and safety of identification of primary nodal drainage for purpose of radiation therapy targeting [ Time Frame: 15 months ]
- - Feasibility of incorporating primary nodal drainage into radiation therapy planning process [ Time Frame: 15 months ]
|Study Start Date:||August 2010|
|Study Completion Date:||April 30, 2017|
|Primary Completion Date:||April 30, 2017 (Final data collection date for primary outcome measure)|
Experimental: pulmonary interstitial lymphography
stereotactic body radiation therapy & pulmonary interstitial lymphography
Procedure: Stereotactic Body Radiation Therapy (SBRT)
standard of careDrug: Iohexol
1 to 5 ccRadiation: Computed Tomography (CT)
For each patient, Chest CT scans will be obtained: 1 before and 2 after interstitial injection of water soluble contrastDevice: 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01188486
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Dr. Billy W. Loo Jr. M.D. Ph.D.||Stanford University|
|Principal Investigator:||Jonathan Abelson||Stanford University|