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A Feasibility Study Using Four-Dimensional CT Imaging to Evaluate Lung Strain in Patients Treated With External Beam Radiation Therapy for Primary Lung Cancer


N/A
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer

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Trial Information

A Feasibility Study Using Four-Dimensional CT Imaging to Evaluate Lung Strain in Patients Treated With External Beam Radiation Therapy for Primary Lung Cancer


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

validate lung strain modeling using 4D-CT in a lung cancer patient population to correlate pre-treatment strain with post-treatment changes.

Outcome Description:

The study will be a prospective, non-randomized, single center, trial to assess and quantify lung strain using 4D-CT treatment planning scans.

Outcome Time Frame:

Pre-treatment (baseline) up to 6 months post-treatment

Safety Issue:

No

Principal Investigator

Neal E Dunlap, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

James Graham Brown Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

BCC-RAD-11-02

NCT ID:

NCT01500876

Start Date:

January 2012

Completion Date:

January 2016

Related Keywords:

  • Lung Cancer
  • lung cancer
  • Lung Neoplasms

Name

Location

James Graham Brown Cancer CenterLouisville, Kentucky  40202