Pulmonary Interstitial Lymphography in Early Stage Lung Cancer

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.

Study Overview

• Status: Terminated
• Conditions: Lung Cancer; Mesothelioma; Lung Cancer Non-Small Cell Cancer (NSCLC); Lung Cancer Small Cell Lung Cancer (SCLC)
• Intervention / Treatment: Radiation: Stereotactic Body Radiation Therapy (SBRT); Radiation: Computed Tomography (CT); Device: Cyberknife; Device: Trilogy; Device: True Beam; Drug: Iohexol; Drug: Iodixanol

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
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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]

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
- Feasibility and safety of identification of primary nodal drainage for purpose of radiation therapy targeting	15 months

Secondary Outcome Measures

Outcome Measure	Time Frame
- Feasibility of incorporating primary nodal drainage into radiation therapy planning process	15 months

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Billy W Loo, Jr, MD, PhD, Stanford University; Principal Investigator: Jonathan Abelson, MD, Stanford University

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): April 30, 2017
• Study Completion (Actual): April 30, 2017

Study Registration Dates

• First Submitted: August 23, 2010
• First Submitted That Met QC Criteria: August 23, 2010
• First Posted (Estimate): August 25, 2010

Study Record Updates

• Last Update Posted (Actual): April 17, 2018
• Last Update Submitted That Met QC Criteria: April 13, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms by Histologic Type; Neoplasms; Lung Diseases; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Adenoma; Neoplasms, Mesothelial; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma; Mesothelioma
• Other Study ID Numbers: IRB-18395; LUN0040 (Other Identifier: OnCore)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No