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

December 5, 2011
May 14, 2013
January 2012
January 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01500876 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
A Feasibility Study Using Four-Dimensional CT Imaging for Primary Lung Cancer
A Feasibility Study Using Four-Dimensional CT Imaging to Evaluate Lung Strain in Patients Treated With External Beam Radiation Therapy for Primary Lung Cancer

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

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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lung Cancer
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
Experimental: Study Arm
Single Arm
Intervention: Radiation: 4D-CT pre-treatment scan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
15
January 2016
January 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Not Provided
United States
 
NCT01500876
BCC-RAD-11-02
Yes
James Graham Brown Cancer Center
James Graham Brown Cancer Center
University of Louisville
Principal Investigator: Neal E Dunlap, MD James Graham Brown Cancer Center
James Graham Brown Cancer Center
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP