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

NCT ID: NCT01500876

Last Updated: 2021-06-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2022-12-31

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.

Conditions

Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study Arm

Single Arm

Group Type: EXPERIMENTAL

4D-CT pre-treatment scan

Intervention Type: RADIATION

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

Interventions

4D-CT pre-treatment scan

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

Intervention Type: RADIATION

Other Intervention Names

planning External Beam Radiation,; 4D-CT study

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

James Graham Brown Cancer Center

OTHER

Sponsor Role: collaborator

University of Louisville

OTHER

Sponsor Role: lead

Responsible Party

Neal Edward Dunlap

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Neal E Dunlap, MD

Role: PRINCIPAL_INVESTIGATOR

James Graham Brown Cancer Center

Locations

James Graham Brown Cancer Center

Louisville, Kentucky, United States

Countries

United States

Other Identifiers

BCC-RAD-11-02

Identifier Type: -

Identifier Source: org_study_id