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A Feasibility Study Using Four-Dimensional CT Imaging for Primary Lung Cancer

Primary Purpose

Lung Cancer

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
4D-CT pre-treatment scan
Sponsored by
University of Louisville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring lung cancer

Eligibility Criteria

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

Inclusion Criteria:

  1. Age >/= 18 years
  2. ECOG performance status 0-1
  3. Pathologic or clinical diagnosis of lung malignancy
  4. Patients must have a reproducible tidal volume sufficient for 4D-CT imaging
  5. Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential.
  6. Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control
  7. Patients must provide study specific informed consent prior to study entry.

Exclusion Criteria:

  1. Patients with severe pulmonary dysfunction with non-reproducible tidal volumes sufficient for 4D-CT imaging.
  2. Pregnant women or lactating women

Sites / Locations

  • James Graham Brown Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study Arm

Arm Description

Single Arm

Outcomes

Primary Outcome Measures

validate lung strain modeling using 4D-CT in a lung cancer patient population to correlate pre-treatment strain with post-treatment changes.
The study will be a prospective, non-randomized, single center, trial to assess and quantify lung strain using 4D-CT treatment planning scans.

Secondary Outcome Measures

correlate 4D-CT based lung strain modeling with standard lung function studies including pulmonary function tests and ventilation-perfusion scans.
4D-CT based lung strain modeling comparison with standard lung function
correlate pre- and post-treatment strain with clinical toxicity
Toxicity correlation
correlate post-treatment strain with radiographic changes to the lung parenchyma
Lung parenchyma correlation

Full Information

First Posted
December 5, 2011
Last Updated
June 21, 2021
Sponsor
University of Louisville
Collaborators
James Graham Brown Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT01500876
Brief Title
A Feasibility Study Using Four-Dimensional CT Imaging for Primary Lung Cancer
Official Title
A Feasibility Study Using Four-Dimensional CT Imaging to Evaluate Lung Strain in Patients Treated With External Beam Radiation Therapy for Primary Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Louisville
Collaborators
James Graham Brown Cancer Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Eligible lung cancer patients: Undergo pre-treatment 4D-CT study for treatment planning External Beam Radiation: standard fractionation (2Gy per day) or stereotactic body radiation therapy Evaluation: Repeat 4D-CT study at 3 months and 6 months post-treatment Primary objectives: To assess pre-treatment global and focal lung strain and correlate with changes post-treatment
Detailed Description
The study will be a prospective, non-randomized, single center, trial to assess and quantify lung strain using four dimensional CT (4D-CT) treatment planning scans. Patients with newly diagnosed lung cancer will be planned using 4D-CT to assess lung and tumor motion. Standard radiation treatment plans will to delivered based on tumor stage. Patients will be reassessed both clinically and radiographically using 4D-CT imaging at 3 months and 6 months post-treatment. Following the initial imaging time points, standard surveillance will be employed with clinical assessment and imaging at 3 month intervals for the first 2 years post-treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
lung cancer

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Study Arm
Arm Type
Experimental
Arm Description
Single Arm
Intervention Type
Radiation
Intervention Name(s)
4D-CT pre-treatment scan
Other Intervention Name(s)
planning External Beam Radiation,, 4D-CT study
Intervention Description
Undergo pre-treatment 4D-CT study for treatment planning External Beam Radiation: standard fractionation (2Gy per day) or stereotactic body radiation therapy Evaluation: Repeat 4D-CT study at 3 months and 6 months post-treatment
Primary Outcome Measure Information:
Title
validate lung strain modeling using 4D-CT in a lung cancer patient population to correlate pre-treatment strain with post-treatment changes.
Description
The study will be a prospective, non-randomized, single center, trial to assess and quantify lung strain using 4D-CT treatment planning scans.
Time Frame
Pre-treatment (baseline) up to 6 months post-treatment
Secondary Outcome Measure Information:
Title
correlate 4D-CT based lung strain modeling with standard lung function studies including pulmonary function tests and ventilation-perfusion scans.
Description
4D-CT based lung strain modeling comparison with standard lung function
Time Frame
2 years post treatment
Title
correlate pre- and post-treatment strain with clinical toxicity
Description
Toxicity correlation
Time Frame
Pre-treatment (baseline) to 2 years post treatment
Title
correlate post-treatment strain with radiographic changes to the lung parenchyma
Description
Lung parenchyma correlation
Time Frame
2 years post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age >/= 18 years ECOG performance status 0-1 Pathologic or clinical diagnosis of lung malignancy Patients must have a reproducible tidal volume sufficient for 4D-CT imaging Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential. Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control Patients must provide study specific informed consent prior to study entry. Exclusion Criteria: Patients with severe pulmonary dysfunction with non-reproducible tidal volumes sufficient for 4D-CT imaging. Pregnant women or lactating women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neal E Dunlap, MD
Organizational Affiliation
James Graham Brown Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
James Graham Brown Cancer Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States

12. IPD Sharing Statement

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A Feasibility Study Using Four-Dimensional CT Imaging for Primary Lung Cancer

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