Clinical trial NCT01500876: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Cancer
Keywords: lung cancer
Lead sponsor: University of Louisville
Sponsor class: OTHER
Collaborators: name: James Graham Brown Cancer Center
First posted: 2011-12-29
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: validate lung strain modeling using 4D-CT in a lung cancer patient population to correlate pre-treatment strain with post-treatment changes.
timeFrame: Pre-treatment (baseline) up to 6 months post-treatment
Secondary outcomes:
measure: correlate 4D-CT based lung strain modeling with standard lung function studies including pulmonary function tests and ventilation-perfusion scans.
timeFrame: 2 years post treatment
measure: correlate pre- and post-treatment strain with clinical toxicity
timeFrame: Pre-treatment (baseline) to 2 years post treatment
measure: correlate post-treatment strain with radiographic changes to the lung parenchyma
timeFrame: 2 years post-treatment
Other outcomes:
Locations:
city: Louisville
country: United States
facility: James Graham Brown Cancer Center
state: Kentucky
Study officials:
affiliation: James Graham Brown Cancer Center
name: Neal E Dunlap, MD
role: PRINCIPAL_INVESTIGATOR
References: