NCT01888510

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable lung-cancer

Timeline
Completed

Started May 2013

Typical duration for not_applicable lung-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 27, 2013

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

July 7, 2016

Status Verified

July 1, 2016

Enrollment Period

3 years

First QC Date

June 25, 2013

Last Update Submit

July 6, 2016

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Amount of inter- and intra-physician contouring variability on 4D CT, ABC CT, free breathing CT, and free breathing and ABC CBCT

    A two sided t-test with 5% level of significance will be used.

    up to 1 week

Secondary Outcomes (2)

  • Magnitude and distribution of target and organ at risk volume variations between the different imaging modalities

    up to 1 week

  • Dosimetric changes related to contouring variations for tumor and normal tissue

    up to 1 week

Study Arms (1)

Diagnostic (imaging studies)

EXPERIMENTAL

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

Procedure: computed tomographyProcedure: 4-dimensional computed tomographyProcedure: cone-beam computed tomography

Interventions

computed tomographyPROCEDURE

Undergo conventional free breathing CT

Also known as: tomography, computed
Diagnostic (imaging studies)
4-dimensional computed tomographyPROCEDURE

Undergo 4D CT

Also known as: 4D-CT
Diagnostic (imaging studies)
cone-beam computed tomographyPROCEDURE

Undergo ABC CBCT

Diagnostic (imaging studies)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Elizabeth Weiss, M.D.

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2013

First Posted

June 27, 2013

Study Start

May 1, 2013

Primary Completion

May 1, 2016

Study Completion

June 1, 2016

Last Updated

July 7, 2016

Record last verified: 2016-07

Locations

US(1)