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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
Sponsor:
Information provided by (Responsible Party):
Billy W. Loo Jr., Stanford University

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.


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

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 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

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
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.
Other Names:
  • Omnipaque
  • Omnipaque in Rediflo prefilled cartridges
  • Bis(2,3-dihydroxypropyl)-5-[N-(2,3-dihydroxypropyl)-acetamido]-2,4,6-triiodoisophthalamide
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.
Other Names:
  • Visipaque
  • 5,5´-[(2-hydroxy-1,3-propanediyl)bis (acetylimino)] bis[N,N´-bis(2,3-dihydroxypropyl)-2,4,6- triiodo-1,3- benzenedicarboxamide]



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 ]


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

INCLUSION CRITERIA

  • Either:

    • Established primary lung cancer/ cancer metastatic to lung, OR
    • Lesion suspicious for malignancy in lung, according to the following criteria:

      • Histopathologically confirmed lung cancer or cancer metastatic to lung, OR
      • 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
      • Known metastatic cancer, with metastases to the lung based on imaging
  • Age > 18 years old
  • Eastern Clinical Oncology Group (ECOG) performance status 0, 1 or 2 (Appendix IV)
  • No prior surgery, chemotherapy, or radiation for the current lung tumor

EXCLUSION CRITERIA

  • Prior radiotherapy to thorax
  • Iodine allergy
  • Contraindication to receiving radiotherapy, unless undergoing surgery
  • 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 ClinicalTrials.gov identifier (NCT number): NCT01188486


Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Billy W Loo, Jr, MD, PhD Stanford University
Principal Investigator: Jonathan Abelson, MD Stanford University

Responsible Party: Billy W. Loo Jr., Associate Professor of Radiation Oncology, Stanford University
ClinicalTrials.gov Identifier: NCT01188486     History of Changes
Other Study ID Numbers: IRB-18395
LUN0040 ( Other Identifier: OnCore )
First Posted: August 25, 2010    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

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