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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
First received
Last updated
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
Health authority
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

Study Design


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
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