CT Perfusion Imaging in Predicting Treatment Response in Patients With Non-small Cell Lung Cancer or Lung Metastases Treated With Stereotactic Ablative Radiation Therapy

Non-Small Cell Lung Carcinoma Clinical Trial

Official title:

A Pilot Study of Perfusion CT for Lung Tumors Treated With Stereotactic Ablative Radiation Therapy (SABR)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02693080
• Other study ID #: IRB-31971
• Secondary ID: NCI-2016-00091LU
• Status: Completed
• Phase: Phase 1
• Start date: January 19, 2016
• Est. completion date: April 29, 2020

Study information

• Verified date: November 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study assesses computed tomography (CT) perfusion imaging in predicting treatment response in patients with non-small cell lung cancer or tumors that have spread from the primary site (place where it started) to the lungs (metastases) treated with stereotactic ablative radiation therapy. CT perfusion imaging is a special type of CT that uses an injected dye in order to see how blood flow through tissues, including lung tissue. CT perfusion imaging of the lungs may help doctors learn whether perfusion characteristics of lung tumors may be predictive of response to treatment and whether lung perfusion characteristics can be used to follow response to treatment.

Description:

PRIMARY OBJECTIVES:

I. To assess the feasibility of performing computed tomography (CT) perfusion imaging (CT perfusion imaging) at baseline, within 48 hours post-stereotactic ablative radiation therapy (SABR), and at 2-4 months SABR in patients undergoing SABR for treatment of a lung tumor per standard of care.

SECONDARY OBJECTIVES:

1. To determine the range (variability) of perfusion parameters at baseline, within 48 hours post-SABR, and at 2-4 months post-SABR

2. To assess the change in perfusion parameters at baseline, within 48 hours post-SABR, and at 2-4 months post-SABR

3. To correlate any change in perfusion parameters with circulating-tumor deoxyribonucleic acid (DNA) levels at baseline, within 48 hours post-SABR, and at 2-4 months post-SABR

4. To correlate perfusion parameters with tumor response 1 year post-SABR

OUTLINE:

Patients receive an infusion of Isovue-200 and undergo CT perfusion imaging of the lungs at baseline, within 48 hours of first SABR, and at 2-4 months after completion of SABR. Cancer Personalized Profiling by Deep Sequencing (CAPP-Seq) will be conducted evaluate circulating-tumor DNA levels.

Perfusion parameters will be correlated with tumor control at 1 year post-SABR, with tumor control defined as no evidence of disease seen at the site of SABR by surveillance imaging at 1 year post-SABR.

After completion of treatment, patients are followed up at 2-4 months and then at 1 year.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: April 29, 2020
• Est. primary completion date: April 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients undergoing SABR for the treatment of a lung tumor, inclusive of non-small cell lung cancer or lung metastases

Exclusion Criteria:

• Patients who are pregnant or are trying to become pregnant are excluded from this study

• Patients with renal failure, defined as glomerular filtration rate (GFR) < 60 at the time of the radiation treatment-planning (RTP) scan, will be excluded

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Malignant Lung Neoplasm
• Metastatic Malignant Neoplasm in the Lung
• Neoplasms
• Non-Small Cell Lung Carcinoma
• Stage IV Lung Cancer

Intervention

Device:
• CAPP-Seq
Cancer Personalized Profiling by Deep Sequencing (CAPP-Seq) is an assay which allows quantitative assessment of the levels of circulating-tumor DNA in the blood sample.

Drug:
• Isovue-200
Contrast agent

Radiation:
• Computed Tomography Perfusion Imaging

Locations

Country	Name	City	State
United States	Stanford University, School of Medicine	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants able to complete perfusion scan acquisition at the time of treatment-planning		Up to approximately 90 seconds
Primary	Number of participants able to complete perfusion scan acquisition within 48 hours of SABR		Within 48 hours post-SABR
Primary	Number of participants able to complete perfusion scan acquisition in follow-up up to 4 months after SABR		Up to 4 months post-SABR
Secondary	The calculated variance of blood flow such that measurable changes can be identified in future studies		Baseline to up to 4 months post-SABR
Secondary	The calculated variance of blood volume such that measurable changes can be identified in future studies		Baseline to up to 4 months post-SABR
Secondary	The calculated variance of mean transit time such that measurable changes can be identified in future studies		Baseline to up to 4 months post-SABR
Secondary	The calculated variance of permeability such that measurable changes can be identified in future studies		Baseline to up to 4 months post-SABR