Pulmonary Interstitial Lymphography in Early Stage Lung Cancer

This study has suspended participant recruitment.
(Interim analysis)
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01188486
First received: August 23, 2010
Last updated: December 16, 2013
Last verified: December 2013
  Purpose

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 Intervention
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
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Pulmonary Interstitial Lymphography in Early Stage Lung Cancer

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • - Feasibility and safety of identification of primary nodal drainage for purpose of radiation therapy targeting [ Time Frame: 15 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • - Feasibility of incorporating primary nodal drainage into radiation therapy planning process [ Time Frame: 15 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: August 2010
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01188486

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

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01188486     History of Changes
Other Study ID Numbers: LUN0040, 18395
Study First Received: August 23, 2010
Last Updated: December 16, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 15, 2014