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

Not Applicable

• Conditions: Lung Cancer
• Interventions: Radiation: 4D-CT pre-treatment scan

• Registration Number: NCT01500876
• Lead Sponsor: University of Louisville

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.

Study Timeline

• Study First Submitted: 2011-12-05
• Study First Submitted QC: 2011-12-28
• Study First Posted: 2011-12-29
• Study Start: 2012-01
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-21
• Last Update Posted: 2021-06-22
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study Arm	4D-CT pre-treatment scan	Single Arm

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
correlate post-treatment strain with radiographic changes to the lung parenchyma	2 years post-treatment	Lung parenchyma correlation
correlate 4D-CT based lung strain modeling with standard lung function studies including pulmonary function tests and ventilation-perfusion scans.	2 years post treatment	4D-CT based lung strain modeling comparison with standard lung function
correlate pre- and post-treatment strain with clinical toxicity	Pre-treatment (baseline) to 2 years post treatment	Toxicity correlation

Trial Locations

Locations (1)

James Graham Brown Cancer Center; 🇺🇸 Louisville, Kentucky, United States