Pulmonary Interstitial Lymphography in Early Stage Lung Cancer

NCT ID: NCT01188486

Last Updated: 2018-04-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2017-04-30

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.

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

pulmonary interstitial lymphography

stereotactic body radiation therapy \& pulmonary interstitial lymphography

Group Type: EXPERIMENTAL

Stereotactic Body Radiation Therapy (SBRT)

Intervention Type: RADIATION

Standard of care diagnostic radiotherapy procedure

Computed Tomography (CT)

Intervention Type: RADIATION

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

Cyberknife

Intervention Type: DEVICE

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

Trilogy

Intervention Type: DEVICE

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

True Beam

Intervention Type: DEVICE

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

Iohexol

Intervention Type: 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.

Iodixanol

Intervention Type: 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.

Interventions

Stereotactic Body Radiation Therapy (SBRT)

Standard of care diagnostic radiotherapy procedure

Intervention Type: 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

Intervention Type: RADIATION

Cyberknife

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

Intervention Type: DEVICE

Trilogy

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

Intervention Type: DEVICE

True Beam

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

Intervention Type: DEVICE

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

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

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Billy W. Loo Jr.

Associate Professor of Radiation Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Billy W Loo, Jr, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Jonathan Abelson, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University School of Medicine

Stanford, California, United States

Countries

United States

Other Identifiers

LUN0040

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-18395

Identifier Type: -

Identifier Source: org_study_id