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Setup Variation in the Supraclavicular Lymph Nodes Treatment in Breast Cancer Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00658281
First received: April 8, 2008
Last updated: January 24, 2013
Last verified: January 2013
History of Changes
  Purpose

The goal of this clinical research study is to use the On Board Imager kilovoltage (OBI KV) system and cone beam computed tomography (CBCT) scanning or CT-on-rail system to look at how well a routine device called an electronic portal imaging device (EPID) can set up a patient to receive radiation therapy on the lymph nodes in the neck.


Condition Intervention
Breast Cancer
 Procedure: CBCT Scan
Procedure: OBI KV Imaging

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Pilot Study of Setup Variation in the Supraclavicular Lymph Nodes Treatment in Breast Cancer Patients Using On-Board Imaging System With Linear Accelerator

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • System Failure (defined as 2 or more disagreements between the EPID and either OBI systems or CT-on-rail from among the 5 evaluations for a particular patient) [ Time Frame: CBCT scanning and OBI R or CT-on-rial system, 5 evaluations per patient, during 5-week radiation treatment period ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: March 2008
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
OBI KV System + CBCT Scanning
Breast cancer patient radiation treatment set up using OBI KV system and CBCT scanning or CT-on-rail system to verify standard EPID for positioning.
 Procedure: CBCT Scan
Cone Beam Computed Tomography (CBCT) scan performed once a week.
Procedure: OBI KV Imaging
On Board Imager kilovoltage (OBI KV) Imaging performed once a week.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients diagnosed with breast cancer.

Criteria

Inclusion Criteria:

  1. Histologically confirmed carcinoma of the breast.
  2. AJCC Stage I-III, or locally recurrent breast cancer
  3. Planned for radiation treatment of the supraclavicular and axillary apex nodal beds using a SCV field
  4. Age greater than or equal to 18 years, since classic breast cancer is a disease of adults
  5. Able to understand the current trial and give informed consent

Exclusion Criteria:

  1. Has bilateral breast cancer requiring radiation to both breasts due to anatomic constraints on planning CT
  2. inflammatory carcinoma due to altered treatment schedule
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00658281

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Xiaochun Wang, PhD M.D. Anderson Cancer Center
  More Information

Additional Information:
MD Anderson Cancer Center  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00658281     History of Changes
Other Study ID Numbers: 2007-0132
Study First Received: April 8, 2008
Last Updated: January 24, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Breast Cancer
On Board Imager Kilovoltage
Cone Beam Computed Tomography
Electronic Portal Imaging Device
 Lymph Nodes
CBCT
OBI KV

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 22, 2013