Clincosm LogoSign in Get a demo

Pulmonary Interstitial Lymphography in Early Stage Lung Cancer

Sponsor
Stanford University (Other)
Overall Status
Terminated
CT.gov ID
NCT01188486
Collaborator
(none)
12
Enrollment
1
Location
1
Arm
81
Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

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
  • Radiation: Stereotactic Body Radiation Therapy (SBRT)
  • Radiation: Computed Tomography (CT)
  • Device: Cyberknife
  • Device: Trilogy
  • Device: True Beam
  • Drug: Iohexol
  • Drug: Iodixanol
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
N/A
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 :
Aug 1, 2010
Actual Primary Completion Date :
Apr 30, 2017
Actual Study Completion Date :
Apr 30, 2017

Arms and Interventions

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]

    		•

    Outcome Measures

    Primary Outcome Measures

    1. - Feasibility and safety of identification of primary nodal drainage for purpose of radiation therapy targeting [15 months]

    Secondary Outcome Measures

    1. - Feasibility of incorporating primary nodal drainage into radiation therapy planning process [15 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Billy W. Loo Jr., Associate Professor of Radiation Oncology, Stanford University
    ClinicalTrials.gov Identifier:
    NCT01188486
    Other Study ID Numbers:
    • IRB-18395
    • LUN0040
    First Posted:
    Aug 25, 2010
    Last Update Posted:
    Apr 17, 2018
    Last Verified:
    Apr 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Lung Neoplasms
    Small Cell Lung Carcinoma
    Mesothelioma
    Carcinoma, Non-Small-Cell Lung

    Study Results

    No Results Posted as of Apr 17, 2018