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

Phase 1

Completed

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

• Registration Number: NCT02693080
• Lead Sponsor: Stanford University

Brief 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.

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 Timeline

• Study Start: 2016-01-19
• Study First Submitted: 2016-01-20
• Study First Submitted QC: 2016-02-25
• Study First Posted: 2016-02-26
• Primary Completion: 2020-04-29
• Study Completion: 2020-04-29
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-21
• Last Update Posted: 2023-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (CT perfusion imaging)	CAPP-Seq	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
Diagnostic (CT perfusion imaging)	Isovue-200	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
Diagnostic (CT perfusion imaging)	Computed Tomography 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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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

Trial Locations

Locations (1)

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