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Trial Title:
A Feasibility Study Using Four-Dimensional CT Imaging for Primary Lung Cancer
NCT ID:
NCT01500876
Condition:
Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Conditions: Keywords:
lung cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
4D-CT pre-treatment scan
Description:
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
Arm group label:
Study Arm
Other name:
planning External Beam Radiation,
Other name:
4D-CT study
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
James Graham Brown Cancer Center
Address:
City:
Louisville
Zip:
40202
Country:
United States
Start date:
January 2012
Completion date:
December 2022
Lead sponsor:
Agency:
University of Louisville
Agency class:
Other
Collaborator:
Agency:
James Graham Brown Cancer Center
Agency class:
Other
Source:
University of Louisville
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01500876
