search
Back to results

Feasibility Study Incorporating Lung Function Imaging Into Radiation Therapy for Lung Cancer Patients

Primary Purpose

Lung Neoplasms, Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Radiation therapy
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Neoplasms focused on measuring Lung cancer, Radiation therapy, 4DCT-ventilation imaging

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Diagnosis of pathologically confirmed lung cancer by tumor biopsy and/or fine-need aspiration
  2. Lung Cancer patients that will undergo definitive radiation therapy defined as 45-75 Gy as part of standard of care for their disease
  3. 18 years of age or older
  4. Signed informed consent
  5. Planned curative intent chemotherapy, delivered concurrently or sequentially in combination with radiotherapy
  6. The patient's 4DCT-ventilation image meets image heterogeneity criteria

Exclusion Criteria:

  1. Patients receiving Stereotactic Body Radiation Therapy
  2. Patient receiving palliative radiation therapy (defined as less than 45 Gy)

Sites / Locations

  • University of Colorado Cancer Center
  • Beaumont Health System

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Radiation therapy

Arm Description

The functional avoidance radiation therapy plan will be delivered using a standard course of radiation treatment on a linear accelerator. Patients will receive daily radiation treatment for 15-35 days.

Outcomes

Primary Outcome Measures

Radiation Safety (Rate of Grade 2 or Higher (Grade 2+) Radiation Pneumonitis as Defined by the Common Toxicity Criteria for Adverse Effects (CTCAE) Scoring System
To assess safety, investigators will evaluate the rate of grade 2 or higher (grade 2+) radiation pneumonitis as defined by the Common Toxicity Criteria for Adverse Effects (CTCAE) scoring system.

Secondary Outcome Measures

Percentage of Patients Eligible for 4DCT-ventilation Functional Avoidance
The percentage will be calculated by taking the ratio of patients that had lung function profiles suitable for functional avoidance and patients that were clinically eligible (receiving 45-75 Gy).

Full Information

First Posted
August 6, 2015
Last Updated
July 21, 2021
Sponsor
University of Colorado, Denver
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT02528942
Brief Title
Feasibility Study Incorporating Lung Function Imaging Into Radiation Therapy for Lung Cancer Patients
Official Title
Early Phase Clinical Trial Incorporating Lung Function Imaging Into Radiation Therapy for Lung Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
April 22, 2016 (Actual)
Primary Completion Date
January 25, 2021 (Actual)
Study Completion Date
January 25, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The proposed study is in the field of thoracic radiation oncology where radiation therapy is used to treat lung cancer. The primary objective of the early phase clinical trial will be to evaluate the safety of performing functional avoidance radiation therapy for lung cancer patients using 4D computed tomography (4DCT) ventilation imaging.
Detailed Description
This study plans to learn more about radiation therapy. Radiation therapy is one of the main treatments used to treat lung cancer. One of the known side effects of this radiation therapy is scarring of the lungs and reduced lung function that can result in shortness of breath. At this time the radiation treatment plan does not take into account differences in lung function between one part of the lung and another. Studies have shown that lung function can vary substantially throughout the lungs. This study aims to plan the radiation therapy to be away from the highest functioning portions of lungs while still delivering the intended radiation dose to the tumor. This study will allow researchers to determine whether taking lung function information into account when designing radiation treatment plans can protect lung function after radiation therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Neoplasms, Lung Cancer
Keywords
Lung cancer, Radiation therapy, 4DCT-ventilation imaging

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Radiation therapy
Arm Type
Experimental
Arm Description
The functional avoidance radiation therapy plan will be delivered using a standard course of radiation treatment on a linear accelerator. Patients will receive daily radiation treatment for 15-35 days.
Intervention Type
Radiation
Intervention Name(s)
Radiation therapy
Intervention Description
Radiation therapy will be given to study patients.
Primary Outcome Measure Information:
Title
Radiation Safety (Rate of Grade 2 or Higher (Grade 2+) Radiation Pneumonitis as Defined by the Common Toxicity Criteria for Adverse Effects (CTCAE) Scoring System
Description
To assess safety, investigators will evaluate the rate of grade 2 or higher (grade 2+) radiation pneumonitis as defined by the Common Toxicity Criteria for Adverse Effects (CTCAE) scoring system.
Time Frame
Up to 14 months
Secondary Outcome Measure Information:
Title
Percentage of Patients Eligible for 4DCT-ventilation Functional Avoidance
Description
The percentage will be calculated by taking the ratio of patients that had lung function profiles suitable for functional avoidance and patients that were clinically eligible (receiving 45-75 Gy).
Time Frame
Up to 14 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of pathologically confirmed lung cancer by tumor biopsy and/or fine-need aspiration Lung Cancer patients that will undergo definitive radiation therapy defined as 45-75 Gy as part of standard of care for their disease 18 years of age or older Signed informed consent Planned curative intent chemotherapy, delivered concurrently or sequentially in combination with radiotherapy The patient's 4DCT-ventilation image meets image heterogeneity criteria Exclusion Criteria: Patients receiving Stereotactic Body Radiation Therapy Patient receiving palliative radiation therapy (defined as less than 45 Gy)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yevgeniy Vinogradskiy, PhD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Cancer Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Beaumont Health System
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48085
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34293726
Citation
Porter EM, Myziuk NK, Quinn TJ, Lozano D, Peterson AB, Quach DM, Siddiqui ZA, Guerrero TM. Synthetic pulmonary perfusion images from 4DCT for functional avoidance using deep learning. Phys Med Biol. 2021 Aug 23;66(17). doi: 10.1088/1361-6560/ac16ec.
Results Reference
derived

Learn more about this trial

Feasibility Study Incorporating Lung Function Imaging Into Radiation Therapy for Lung Cancer Patients

We'll reach out to this number within 24 hrs