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

University of Louisville35 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lung Cancer

Interventions

4D-CT pre-treatment scanRADIATION

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

James Graham Brown Cancer Center

Louisville, Kentucky, United States

Outcomes

Primary Outcomes

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

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

Time frame: Pre-treatment (baseline) up to 6 months post-treatment

Secondary Outcomes

correlate 4D-CT based lung strain modeling with standard lung function studies including pulmonary function tests and ventilation-perfusion scans.

4D-CT based lung strain modeling comparison with standard lung function

Time frame: 2 years post treatment

correlate pre- and post-treatment strain with clinical toxicity

Toxicity correlation

Time frame: Pre-treatment (baseline) to 2 years post treatment

correlate post-treatment strain with radiographic changes to the lung parenchyma

Lung parenchyma correlation

Time frame: 2 years post-treatment

Data from ClinicalTrials.gov

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