Pulmonary Interstitial Lymphography in Early Stage Lung Cancer

Not Applicable

Terminated

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

• Registration Number: NCT01188486
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-08-23
• Study First Submitted QC: 2010-08-23
• Study First Posted: 2010-08-25
• Primary Completion: 2017-04-30
• Study Completion: 2017-04-30
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-13
• Last Update Posted: 2018-04-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
pulmonary interstitial lymphography	Stereotactic Body Radiation Therapy (SBRT)	stereotactic body radiation therapy \& pulmonary interstitial lymphography
pulmonary interstitial lymphography	Computed Tomography (CT)	stereotactic body radiation therapy \& pulmonary interstitial lymphography
pulmonary interstitial lymphography	Cyberknife	stereotactic body radiation therapy \& pulmonary interstitial lymphography
pulmonary interstitial lymphography	Trilogy	stereotactic body radiation therapy \& pulmonary interstitial lymphography
pulmonary interstitial lymphography	True Beam	stereotactic body radiation therapy \& pulmonary interstitial lymphography
pulmonary interstitial lymphography	Iohexol	stereotactic body radiation therapy \& pulmonary interstitial lymphography
pulmonary interstitial lymphography	Iodixanol	stereotactic body radiation therapy \& pulmonary interstitial lymphography

Primary Outcome Measures

Name	Time	Method
- Feasibility and safety of identification of primary nodal drainage for purpose of radiation therapy targeting	15 months

Secondary Outcome Measures

Name	Time	Method
- Feasibility of incorporating primary nodal drainage into radiation therapy planning process	15 months

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States