Stereotactic Image-Guided Navigation During Breast Reconstruction in Patients With Breast Cancer
Primary Purpose
Ductal Breast Carcinoma in Situ, Lobular Breast Carcinoma in Situ, Recurrent Breast Cancer
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
breast reconstruction
intraoperative imaging
Sponsored by
About this trial
This is an interventional supportive care trial for Ductal Breast Carcinoma in Situ
Eligibility Criteria
Inclusion Criteria:
- Patients with histologically confirmed breast carcinoma or breast carcinoma in situ desiring unilateral or bilateral deep inferior epigastric perforator (DIEP) flap breast reconstruction
- Patients must be candidates for elective surgery, without clinically significant cardiac or pulmonary disease (New York Heart Association [NYHA] class III/IV), without infection requiring antibiotics, and without serious illness requiring the use of steroids
- Patients must have normal kidney function and no allergy to intravenous (IV) dye
Exclusion Criteria:
- Patients with previous abdominal donor site flaps will be excluded along with patients with previous extensive surgery to the anterior abdomen
- Patients with a weight of over 300 pounds or a body size not supported by the CT scanner will be excluded
- Patients who are expected to undergo postoperative radiation therapy will be excluded
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Supportive care (image-guided breast reconstruction)
Arm Description
Patients undergo DIEP flap breast reconstruction using the StealthStation navigation system.
Outcomes
Primary Outcome Measures
The number of perforators that are found intraoperatively but not seen preoperatively on CT angiogram images
Whether the preoperative CT angiography allowed the surgeon to accurately predict the perforator vessels that were actually used in the final flap design and transfer
Secondary Outcome Measures
Position of the vessels on the imaging correlate to actual location on the abdominal wall for those perforator vessels that are identified both on preoperative review of the images and located during flap dissection
Full Information
NCT ID
NCT01729832
First Posted
November 14, 2012
Last Updated
April 12, 2017
Sponsor
Ohio State University Comprehensive Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT01729832
Brief Title
Stereotactic Image-Guided Navigation During Breast Reconstruction in Patients With Breast Cancer
Official Title
Intraoperative Stereotactic Image-guided Navigation of Perforators for DIEP Flap Breast Reconstruction.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Withdrawn
Study Start Date
January 10, 2011 (Actual)
Primary Completion Date
July 2012 (Anticipated)
Study Completion Date
July 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ohio State University Comprehensive Cancer Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Many hospitals, including the Ohio State University Medical Center, will take pictures of the blood vessels in a patient's abdomen before they decide to perform a breast reconstruction using the patient's own tissue. These pictures are called computed tomography (CT) angiograms and are like a map of each patient's anatomy. However, no study has been reported that determined how accurate these pictures are at showing the surgeon where all of the blood vessels were located. This study will try to determine if these pictures are missing any blood vessels that are found during surgery and if the pictures show the correct location of the vessels
Detailed Description
PRIMARY OBJECTIVES:
I. To analyze the accuracy of preoperative CT angiography in determining the location of perforator vessels. Through the use of an intraoperative navigation system, we will objectively locate perforators during surgery and compare the results to the preoperative imaging assessment of the flap's vascular anatomy.
II. To determine whether the preoperative CT angiogram allows the microsurgeon to correctly identify the perforators that are ultimately used as the pedicle for the flap.
OUTLINE:
Patients undergo deep inferior epigastric perforator (DIEP) flap breast reconstruction using the StealthStation navigation system.
After completion of study treatment, patients are followed up at 1-2 weeks and 1 month, then every 3 months for 2 years.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ductal Breast Carcinoma in Situ, Lobular Breast Carcinoma in Situ, Recurrent Breast Cancer, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer, Stage IV Breast Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Supportive care (image-guided breast reconstruction)
Arm Type
Experimental
Arm Description
Patients undergo DIEP flap breast reconstruction using the StealthStation navigation system.
Intervention Type
Procedure
Intervention Name(s)
breast reconstruction
Other Intervention Name(s)
Mammaplasty
Intervention Description
Undergo DIEP flap breast reconstruction using the StealthStation navigation system
Intervention Type
Procedure
Intervention Name(s)
intraoperative imaging
Intervention Description
Undergo DIEP flap breast reconstruction using the StealthStation navigation system
Primary Outcome Measure Information:
Title
The number of perforators that are found intraoperatively but not seen preoperatively on CT angiogram images
Time Frame
Up to 2 years
Title
Whether the preoperative CT angiography allowed the surgeon to accurately predict the perforator vessels that were actually used in the final flap design and transfer
Time Frame
Up to 2 years
Secondary Outcome Measure Information:
Title
Position of the vessels on the imaging correlate to actual location on the abdominal wall for those perforator vessels that are identified both on preoperative review of the images and located during flap dissection
Time Frame
Up to 2 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with histologically confirmed breast carcinoma or breast carcinoma in situ desiring unilateral or bilateral deep inferior epigastric perforator (DIEP) flap breast reconstruction
Patients must be candidates for elective surgery, without clinically significant cardiac or pulmonary disease (New York Heart Association [NYHA] class III/IV), without infection requiring antibiotics, and without serious illness requiring the use of steroids
Patients must have normal kidney function and no allergy to intravenous (IV) dye
Exclusion Criteria:
Patients with previous abdominal donor site flaps will be excluded along with patients with previous extensive surgery to the anterior abdomen
Patients with a weight of over 300 pounds or a body size not supported by the CT scanner will be excluded
Patients who are expected to undergo postoperative radiation therapy will be excluded
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ergun Kocak, MD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Links:
URL
http://cancer.osu.edu
Description
Jamesline
Learn more about this trial
Stereotactic Image-Guided Navigation During Breast Reconstruction in Patients With Breast Cancer
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