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

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

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.

Study Overview

• Status: Completed
• Conditions: Stage IV Lung Cancer; Metastatic Malignant Neoplasm in the Lung; Non-Small Cell Lung Carcinoma; Malignant Lung Neoplasm
• Intervention / Treatment: Device: CAPP-Seq; Drug: Isovue-200; Radiation: Computed Tomography Perfusion Imaging

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Stanford University, School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diagnostic (CT perfusion imaging); Patients undergo CT perfusion imaging of the lungs at baseline, within 48 hours of first SABR, and at 2-4 months after completion of SABR. Isovue-200 is used as contrast agent	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.; Other Names: Cancer Personalized Profiling by Deep Sequencing; Drug: Isovue-200; Contrast agent; Other Names: Lopamidol; Radiation: Computed Tomography Perfusion Imaging; Other Names: CT Perfusion Imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants able to complete perfusion scan acquisition at the time of treatment-planning	Up to approximately 90 seconds
Number of participants able to complete perfusion scan acquisition within 48 hours of SABR	Within 48 hours post-SABR
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 Outcome Measures

Outcome Measure	Time Frame
The calculated variance of blood flow such that measurable changes can be identified in future studies	Baseline to up to 4 months post-SABR
The calculated variance of blood volume such that measurable changes can be identified in future studies	Baseline to up to 4 months post-SABR
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
The calculated variance of permeability such that measurable changes can be identified in future studies	Baseline to up to 4 months post-SABR

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Maximilian Diehn, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2016
• Primary Completion (Actual): April 29, 2020
• Study Completion (Actual): April 29, 2020

Study Registration Dates

• First Submitted: January 20, 2016
• First Submitted That Met QC Criteria: February 25, 2016
• First Posted (Estimated): February 26, 2016

Study Record Updates

• Last Update Posted (Actual): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 21, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: IRB-31971 (Other Identifier: Stanford IRB); NCI-2016-00091 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); LUN0072 (Other Identifier: OnCore)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No