Trial record 6 of 530 for:    Open Studies | "Tomography, X-Ray Computed"

CT in Diagnosing Patients With Lung Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Virginia Commonwealth University
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01888510
First received: June 25, 2013
Last updated: June 20, 2014
Last verified: June 2014
  Purpose

This clinical trial studies computed tomography (CT) in diagnosing patients with lung cancer. Diagnostic procedures, such as CT, may help find and diagnose lung cancer.


Condition Intervention
Lung Cancer
Procedure: computed tomography
Procedure: 4-dimensional computed tomography
Procedure: cone-beam computed tomography

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Comparison of Conventional Free Breathing CT, 4D CT, and Integrated Active Breath Hold CT Image Acquisition for Lung Cancer

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • Amount of inter- and intra-physician contouring variability on 4D CT, ABC CT, free breathing CT, and free breathing and ABC CBCT [ Time Frame: up to 1 week ] [ Designated as safety issue: No ]
    A two sided t-test with 5% level of significance will be used.


Secondary Outcome Measures:
  • Magnitude and distribution of target and organ at risk volume variations between the different imaging modalities [ Time Frame: up to 1 week ] [ Designated as safety issue: No ]
    A two sided t-test with 5% level of significance will be used.

  • Dosimetric changes related to contouring variations for tumor and normal tissue [ Time Frame: up to 1 week ] [ Designated as safety issue: No ]
    A two sided t-test with 5% level of significance will be used.


Estimated Enrollment: 10
Study Start Date: May 2013
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diagnostic (imaging studies)
Patients undergo conventional free breathing CT, 4D CT, ABC CT, ABC CBCT, and free breathing CBCT before undergoing radiation therapy.
Procedure: computed tomography
Undergo conventional free breathing CT
Other Name: tomography, computed
Procedure: 4-dimensional computed tomography
Undergo 4D CT
Other Name: 4D-CT
Procedure: computed tomography
Undergo ABC CT
Other Name: tomography, computed
Procedure: cone-beam computed tomography
Undergo ABC CBCT
Procedure: cone-beam computed tomography
Undergo free breathing CBCT

Detailed Description:

PRIMARY OBJECTIVES:

I. Conduct a prospective clinical imaging study to quantify the amount of inter- and intra-physician contouring variability on four dimensional (4D) CT, active breathing control (ABC) CT, free breathing CT, and free breathing and ABC cone beam (CB)CT.

II. Quantify the magnitude and distribution of target and organ at risk volume variations between the different imaging modalities.

III. Determine dosimetric changes related to contouring variations for tumor and normal tissue.

OUTLINE:

Patients undergo conventional free breathing CT, 4D CT, ABC CT, ABC CBCT, and free breathing CBCT before undergoing radiation therapy.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Measurable disease on CT scan
  • Patients with lung cancer visible on CT who are scheduled to receive external beam radiation treatment will be eligible for this study
  • Patients must be able to perform ABC procedures

Exclusion Criteria:

  • Patients requiring continuous supplemental oxygen due to the requirement of spirometry during all imaging studies
  • No vulnerable populations will be enrolled (prisoners, children, pregnant females or institutionalized individuals)
  • Women of childbearing potential will undergo a pregnancy test
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01888510

Contacts
Contact: Elisabeth Weiss, MD 804-828-9463 eweiss@mcvh-vcu.edu

Locations
United States, Virginia
Virginia Commonwealth University/Massey Cancer Center Recruiting
Richmond, Virginia, United States, 23298
Contact: Elisabeth Weiss, MD    804-828-9463    eweiss@mcvh-vcu.edu   
Principal Investigator: Elisabeth Weiss, MD         
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Principal Investigator: Elizabeth Weiss, M.D. Virginia Commonwealth University
  More Information

No publications provided

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01888510     History of Changes
Other Study ID Numbers: MCC-015032, NCI-2013-01163
Study First Received: June 25, 2013
Last Updated: June 20, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 28, 2014