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

This study is currently recruiting participants.
Verified May 2013 by James Graham Brown Cancer Center
Sponsor:
Collaborator:
University of Louisville
Information provided by (Responsible Party):
James Graham Brown Cancer Center
ClinicalTrials.gov Identifier:
NCT01500876
First received: December 5, 2011
Last updated: May 14, 2013
Last verified: May 2013
History of Changes
  Purpose

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


Condition Intervention
Lung Cancer
 Radiation: 4D-CT pre-treatment scan

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by James Graham Brown Cancer Center:

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. [ Time Frame: Pre-treatment (baseline) up to 6 months post-treatment ] [ Designated as safety issue: No ]
    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. [ Time Frame: 2 years post treatment ] [ Designated as safety issue: No ]
    4D-CT based lung strain modeling comparison with standard lung function

  • correlate pre- and post-treatment strain with clinical toxicity [ Time Frame: Pre-treatment (baseline) to 2 years post treatment ] [ Designated as safety issue: Yes ]
    Toxicity correlation

  • correlate post-treatment strain with radiographic changes to the lung parenchyma [ Time Frame: 2 years post-treatment ] [ Designated as safety issue: No ]
    Lung parenchyma correlation


Estimated Enrollment: 15
Study Start Date: January 2012
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Study Arm
Single Arm
 Radiation: 4D-CT pre-treatment scan
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
Other Names:
  • planning External Beam Radiation,
  • 4D-CT study

Detailed Description:

The study will be a prospective, non-randomized, single center, trial to assess and quantify lung strain using 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01500876

Locations
United States, Kentucky
James Graham Brown Cancer Center Recruiting
Louisville, Kentucky, United States, 40202
Contact: Teresa Roberts, RN     502-333-6934     tlrobe14@exchange.louisville.edu    
Contact: Neal Dunlap, MD     502-562-4360     nedunl01@louisville.edu    
Principal Investigator: Neal E Dunlap, MD            
Sub-Investigator: Shiao Woo, MD            
Sub-Investigator: Amir Amini, MD            
Sponsors and Collaborators
James Graham Brown Cancer Center
University of Louisville
Investigators
Principal Investigator: Neal E Dunlap, MD James Graham Brown Cancer Center
  More Information

No publications provided

Responsible Party: James Graham Brown Cancer Center
ClinicalTrials.gov Identifier: NCT01500876     History of Changes
Other Study ID Numbers: BCC-RAD-11-02
Study First Received: December 5, 2011
Last Updated: May 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by James Graham Brown Cancer Center:
lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 21, 2013