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



Status:Active, not recruiting
Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/7/2018
Start Date:January 2012
End Date:December 2018

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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

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 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.

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
We found this trial at
1
site
529 S Jackson St
Louisville, Kentucky 40202
(502) 562-4369
Principal Investigator: Neal E Dunlap, MD
Phone: 502-333-6934
James Graham Brown Cancer Center No one should feel compelled to leave Kentucky to seek...
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Louisville, KY
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