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Completed

NCT Number: NCT02693080

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

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.

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Key information

Conditions

Malignant Lung Neoplasm Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Metastatic Malignant Neoplasm in the Lung Neoplasms Neoplasms by Site Non-small Cell Lung Carcinoma Respiratory Tract Diseases Respiratory Tract Neoplasms Stage IV Lung Cancer Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Stanford University, School of Medicine

Palo Alto, California, 94304, United States

About this study

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:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CAPP-Seq

Device

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

Isovue-200

Drug

Contrast agent

Other names: Lopamidol

Computed Tomography Perfusion Imaging

Radiation

Other names: CT Perfusion Imaging

Primary outcomes

  1. Number of participants able to complete perfusion scan acquisition at the time of treatment-planning

    Time frame: Up to approximately 90 seconds

  2. Number of participants able to complete perfusion scan acquisition within 48 hours of SABR

    Time frame: Within 48 hours post-SABR

  3. Number of participants able to complete perfusion scan acquisition in follow-up up to 4 months after SABR

    Time frame: Up to 4 months post-SABR

Secondary outcomes

  1. The calculated variance of blood flow such that measurable changes can be identified in future studies

    Time frame: Baseline to up to 4 months post-SABR

  2. The calculated variance of blood volume such that measurable changes can be identified in future studies

    Time frame: Baseline to up to 4 months post-SABR

  3. The calculated variance of mean transit time such that measurable changes can be identified in future studies

    Time frame: Baseline to up to 4 months post-SABR

  4. The calculated variance of permeability such that measurable changes can be identified in future studies

    Time frame: Baseline to up to 4 months post-SABR

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Feb 26, 2016
Registry last updated
Nov 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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