Ultrasound Based Localization of Lumpectomy Bed in Anatomical Coordinate System

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00681304
First received: May 19, 2008
Last updated: November 15, 2012
Last verified: November 2012

May 19, 2008
November 15, 2012
August 2007
June 2012   (final data collection date for primary outcome measure)
Describe the concordance between the lumpectomy bed's center-of-mass (COM) as determined by USEI and CT [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00681304 on ClinicalTrials.gov Archive Site
Describe the concordance between the lumpectomy bed volume as measured by USEI and CT. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Ultrasound Based Localization of Lumpectomy Bed in Anatomical Coordinate System
"Ultrasound Based Localization of Lumpectomy Bed in Anatomical Coordinate System" (J-0728)

This is a pilot study. The main purposes for doing the study are to see if there is a relationship between lumpectomy volume and position as measured by USEI and by CT. This is not a study to see if the use of USEI is better than the current method of using CT for daily radiation therapy positioning.

1. Abstract The feasibility, toxicity and efficacy of Partial Brest Irradiation (PBI) are currently being studied by major cooperative groups such as the NSABP, and RTOG as well as by several major academic institutions. PBI entails definitive radiation to the lumpectomy site while minimizing radiation to the remaining breast tissue. The success of PBI is dependent in no small part to proper target localization. In radiation therapy, to treat an internal structure, external landmarks must be used to calculate the position of the internal target. These external landmarks can easily change in a non-rigid structure (e.g. breast), which would nullify their use as a reference. To address this problem, there have been recent advances in the application of ultrasound (US) technology in target localization especially with respect to the prostate. Transcutaneous tracked US emerged as the most suitable non-invasive daily prostate localization tool. In this procedure an US probe is tracked and spatially registered with respect to the treatment machine, linear accelerator. Thus if one localizes the target anatomy in the US images, then the position of the target is automatically known with respect to the linear accelerator, so that the accelerator can be correctly aimed.

Unfortunately, contemporary US imaging is not sufficiently sensitive to delineate the lumpectomy bed for PBI. We propose to supplant B-mode imaging with a novel US elasticity imaging (USEI) method to delineate the subtle and complex boundaries of the lumpectomy cavity. Our preliminary studies suggest that USEI may be superior to B-mode imaging (see statistical section and Ref. 6-7). However our work was only done in ex-vivo tissue models. In the literature, there are many studies showing the superior sensitivity and specificity of strain imaging compared to regular B-mode imaging7.

The benefit of developing a way to use ultrasound for target localization is clear. Identification of the target would no longer be dependent on unreliable external landmarks but now on direct internal information. As a consequence, targeting errors, most commonly associated with patient positioning, could be significantly reduced or practically eliminated. Thus, we propose to study the ability of USEI to detect and characterize the lumpectomy bed in-vivo using CT data as ground truth. We will pursue our work in two specific aims:

Aim 1: Describe the concordance between the lumpectomy bed's center-of-mass (COM) as determined by USEI and CT.

Aim 2: Describe the concordance between the lumpectomy bed volume as measured by USEI and CT.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Women with breast cancer, who are status post lumpectomy and are scheduled to have radiation therapy, will be eligible.

  • Resected Breast Cancer
  • Breast Cancer
Other: ultrasound scan
The only study procedure involved in this project is for subjects to undergo an ultrasound scan during their radiation therapy simulation. The ultrasound is done at this time, so it can be co-registered to the routine breast treatment planning CT scan.
1
Only one group of participants will be studies. There are no controls.
Intervention: Other: ultrasound scan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
July 2012
June 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Women with breast cancer, who are status post lumpectomy and are scheduled to have radiation therapy, will be eligible.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00681304
J-0728, NA_00010252
No
Sidney Kimmel Comprehensive Cancer Center
Sidney Kimmel Comprehensive Cancer Center
Not Provided
Principal Investigator: Richard Zellars, M.D. Johns Hopkins University
Sidney Kimmel Comprehensive Cancer Center
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP