- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01500876
A Feasibility Study Using Four-Dimensional CT Imaging for Primary Lung Cancer
June 21, 2021 updated by: Neal Edward Dunlap, University of Louisville
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
Study Overview
Status
Active, not recruiting
Conditions
Intervention / 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.
Study Type
Interventional
Enrollment (Actual)
35
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kentucky
-
Louisville, Kentucky, United States, 40202
- James Graham Brown Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age >/= 18 years
- ECOG performance status 0-1
- Pathologic or clinical diagnosis of lung malignancy
- Patients must have a reproducible tidal volume sufficient for 4D-CT imaging
- Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential.
- Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control
- Patients must provide study specific informed consent prior to study entry.
Exclusion Criteria:
- Patients with severe pulmonary dysfunction with non-reproducible tidal volumes sufficient for 4D-CT imaging.
- Pregnant women or lactating women
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Study Arm
Single Arm
|
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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
validate lung strain modeling using 4D-CT in a lung cancer patient population to correlate pre-treatment strain with post-treatment changes.
Time Frame: Pre-treatment (baseline) up to 6 months post-treatment
|
The study will be a prospective, non-randomized, single center, trial to assess and quantify lung strain using 4D-CT treatment planning scans.
|
Pre-treatment (baseline) up to 6 months post-treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
correlate 4D-CT based lung strain modeling with standard lung function studies including pulmonary function tests and ventilation-perfusion scans.
Time Frame: 2 years post treatment
|
4D-CT based lung strain modeling comparison with standard lung function
|
2 years post treatment
|
correlate pre- and post-treatment strain with clinical toxicity
Time Frame: Pre-treatment (baseline) to 2 years post treatment
|
Toxicity correlation
|
Pre-treatment (baseline) to 2 years post treatment
|
correlate post-treatment strain with radiographic changes to the lung parenchyma
Time Frame: 2 years post-treatment
|
Lung parenchyma correlation
|
2 years post-treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Neal E Dunlap, MD, James Graham Brown Cancer Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (ANTICIPATED)
December 1, 2022
Study Completion (ANTICIPATED)
December 1, 2022
Study Registration Dates
First Submitted
December 5, 2011
First Submitted That Met QC Criteria
December 28, 2011
First Posted (ESTIMATE)
December 29, 2011
Study Record Updates
Last Update Posted (ACTUAL)
June 22, 2021
Last Update Submitted That Met QC Criteria
June 21, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BCC-RAD-11-02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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