Pulmonary Interstitial Lymphography in Early Stage Lung Cancer

NCT01188486 | Terminated DMC FDA Device

• 2 other identifiers: IRB-18395LUN0040
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer; Lung Cancer Non-Small Cell Cancer (NSCLC); Lung Cancer Small Cell Lung Cancer (SCLC); Mesothelioma

Outcome Measures

Primary Outcomes (1)

• - Feasibility and safety of identification of primary nodal drainage for purpose of radiation therapy targeting

  15 months

Secondary Outcomes (1)

• - Feasibility of incorporating primary nodal drainage into radiation therapy planning process

  15 months

Study Arms (1)

pulmonary interstitial lymphography

EXPERIMENTAL

stereotactic body radiation therapy \& pulmonary interstitial lymphography

Radiation: Stereotactic Body Radiation Therapy (SBRT); Radiation: Computed Tomography (CT); Device: Cyberknife; Device: Trilogy; Device: True Beam; Drug: Iohexol; Drug: Iodixanol

Interventions

Stereotactic Body Radiation Therapy (SBRT) RADIATION

Standard of care diagnostic radiotherapy procedure

pulmonary interstitial lymphography

Computed Tomography (CT) RADIATION

For each participant, 3 chest CT scans will be obtained, 1 before and 2 after interstitial injection of the water-soluble contrast

pulmonary interstitial lymphography

Cyberknife DEVICE

Linear accelerator for producing high energy x-rays for radiation therapy.

pulmonary interstitial lymphography

Trilogy DEVICE

Linear accelerator for producing high energy x-rays for radiation therapy.

pulmonary interstitial lymphography

True Beam DEVICE

Linear accelerator for producing high energy x-rays for radiation therapy.

pulmonary interstitial lymphography

Iohexol DRUG

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.

Also known as: Omnipaque, Omnipaque in Rediflo prefilled cartridges, Bis(2,3-dihydroxypropyl)-5-[N-(2,3-dihydroxypropyl)-acetamido]-2,4,6-triiodoisophthalamide

pulmonary interstitial lymphography

Iodixanol DRUG

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.

Also known as: Visipaque, 5,5´-[(2-hydroxy-1,3-propanediyl)bis (acetylimino)] bis[N,N´-bis(2,3-dihydroxypropyl)-2,4,6- triiodo-1,3- benzenedicarboxamide]

pulmonary interstitial lymphography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Prior radiotherapy to thorax
• Iodine allergy
• Contraindication to receiving radiotherapy, unless undergoing surgery
• Pregnant

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma; Mesothelioma

Interventions

Radiosurgery; Iohexol; iodixanol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques; Triiodobenzoic Acids; Iodobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Billy W Loo, Jr, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Jonathan Abelson, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Radiation Oncology

Study Record Dates

• First Submitted: August 23, 2010
• First Posted: August 25, 2010
• Study Start: August 1, 2010
• Primary Completion: April 30, 2017
• Study Completion: April 30, 2017
• Last Updated: April 17, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)