Pulmonary Interstitial Lymphography in Early Stage Lung Cancer
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|ClinicalTrials.gov Identifier: NCT01188486|
Recruitment Status : Terminated (Business decision)
First Posted : August 25, 2010
Last Update Posted : April 17, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer Lung Cancer Non-Small Cell Cancer (NSCLC) Lung Cancer Small Cell Lung Cancer (SCLC) Mesothelioma||Radiation: Stereotactic Body Radiation Therapy (SBRT) Radiation: Computed Tomography (CT) Device: Cyberknife Device: Trilogy Device: True Beam Drug: Iohexol Drug: Iodixanol||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|Official Title:||Pulmonary Interstitial Lymphography in Early Stage Lung Cancer|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||April 30, 2017|
|Actual Study Completion Date :||April 30, 2017|
Experimental: pulmonary interstitial lymphography
stereotactic body radiation therapy & pulmonary interstitial lymphography
Radiation: Stereotactic Body Radiation Therapy (SBRT)
Standard of care diagnostic radiotherapy procedureRadiation: Computed Tomography (CT)
For each participant, 3 chest CT scans will be obtained, 1 before and 2 after interstitial injection of the 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.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.
Other Names: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.
- - 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01188486
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Billy W Loo, Jr, MD, PhD||Stanford University|
|Principal Investigator:||Jonathan Abelson, MD||Stanford University|