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

NCT01500876 | Unknown DMC

• 1 other identifier: BCC-RAD-11-02
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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

Conditions

Lung Cancer

Keywords

lung cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  Pre-treatment (baseline) up to 6 months post-treatment

Secondary Outcomes (3)

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

  2 years post treatment

• correlate pre- and post-treatment strain with clinical toxicity

  Pre-treatment (baseline) to 2 years post treatment

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

  2 years post-treatment

Study Arms (1)

Study Arm

EXPERIMENTAL

Single Arm

Radiation: 4D-CT pre-treatment scan

Interventions

4D-CT pre-treatment scan 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

Also known as: planning External Beam Radiation,, 4D-CT study

Study Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with severe pulmonary dysfunction with non-reproducible tidal volumes sufficient for 4D-CT imaging.
• Pregnant women or lactating women

Sponsors & Collaborators

• University of Louisville: lead
• James Graham Brown Cancer Center: collaborator

Study Sites (1)

James Graham Brown Cancer Center

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Neal E Dunlap, MD

  James Graham Brown Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 5, 2011
• First Posted: December 29, 2011
• Study Start: January 1, 2012
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: June 22, 2021

Record last verified: 2021-06

Locations

US (1)