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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 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 19, 2014
Last verified: May 2014
  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:


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: December 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 19, 2014
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 August 21, 2014