Original Query: "Lung Neoplasms"
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Pulmonary Interstitial Lymphography in Early Stage Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01188486
Recruitment Status : Terminated (business decision)
First Posted : August 25, 2010
Last Update Posted : May 8, 2017
Information provided by (Responsible Party):
Billy W. Loo Jr., Stanford University

Brief Summary:

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.

Condition or disease Intervention/treatment
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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pulmonary Interstitial Lymphography in Early Stage Lung Cancer
Study Start Date : August 2010
Primary Completion Date : April 30, 2017
Study Completion Date : April 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: pulmonary interstitial lymphography
stereotactic body radiation therapy & pulmonary interstitial lymphography
Procedure: Stereotactic Body Radiation Therapy (SBRT)
standard of care
Drug: Iohexol
1 to 5 cc
Radiation: Computed Tomography (CT)
For each patient, Chest CT scans will be obtained: 1 before and 2 after interstitial injection of 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.

Primary Outcome Measures :
  1. - Feasibility and safety of identification of primary nodal drainage for purpose of radiation therapy targeting [ Time Frame: 15 months ]

Secondary Outcome Measures :
  1. - Feasibility of incorporating primary nodal drainage into radiation therapy planning process [ Time Frame: 15 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:- Either 1. Established primary lung cancer/ cancer metastatic to lung, OR 2. Lesion suspicious for malignancy in lung, according to the following criteria:

A. Histopathologically confirmed lung cancer or cancer metastatic to lung, OR B. Plan for biopsy of suspicious lung mass based on imaging (growth on serial CT scan or nodule/mass with focal hypermetabolism on FDG-PET scan), OR C. Known metastatic cancer, with metastases to the lung based on imaging

  • Age > 18 years old
  • Eastern Clinical Oncology Group performance status 0, 1 or 2 (Appendix IV)
  • No prior surgery, chemotherapy, or radiation for the current lung tumor
  • Both men and women and members of all races and ethnic groups are eligible for this trial.

Exclusion Criteria:- Prior radiotherapy to thorax

  • Allergy to iodine
  • Contraindication to receiving radiotherapy, unless undergoing surgery
  • Women who are pregnant

Information from the National Library of Medicine

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 identifier (NCT number): NCT01188486

United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Principal Investigator: Dr. Billy W. Loo Jr. M.D. Ph.D. Stanford University
Principal Investigator: Jonathan Abelson Stanford University

Responsible Party: Billy W. Loo Jr., Associate Professor of Radiation Oncology, Stanford University Identifier: NCT01188486     History of Changes
Other Study ID Numbers: LUN0040
18395 ( Other Identifier: SU IRB )
First Posted: August 25, 2010    Key Record Dates
Last Update Posted: May 8, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial