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Stereotactic Image-Guided Navigation During Breast Reconstruction in Patients With Breast Cancer

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ClinicalTrials.gov Identifier: NCT01729832
Recruitment Status : Withdrawn
First Posted : November 20, 2012
Last Update Posted : April 13, 2017
Sponsor:
Information provided by (Responsible Party):
Ohio State University Comprehensive Cancer Center

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

Condition or disease Intervention/treatment Phase
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 Procedure: breast reconstruction Procedure: intraoperative imaging Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Intraoperative Stereotactic Image-guided Navigation of Perforators for DIEP Flap Breast Reconstruction.
Actual Study Start Date : January 10, 2011
Estimated Primary Completion Date : July 2012
Estimated Study Completion Date : July 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Supportive care (image-guided breast reconstruction)
Patients undergo DIEP flap breast reconstruction using the StealthStation navigation system.
Procedure: breast reconstruction
Undergo DIEP flap breast reconstruction using the StealthStation navigation system
Other Name: Mammaplasty

Procedure: intraoperative imaging
Undergo DIEP flap breast reconstruction using the StealthStation navigation system




Primary Outcome Measures :
  1. The number of perforators that are found intraoperatively but not seen preoperatively on CT angiogram images [ Time Frame: Up to 2 years ]
  2. 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 Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01729832


Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
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Principal Investigator: Ergun Kocak, MD Ohio State University

Additional Information:
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Responsible Party: Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01729832     History of Changes
Other Study ID Numbers: OSU-10106
NCI-2012-00693 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: November 20, 2012    Key Record Dates
Last Update Posted: April 13, 2017
Last Verified: April 2017
Additional relevant MeSH terms:
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Carcinoma
Breast Neoplasms
Carcinoma in Situ
Carcinoma, Ductal, Breast
Breast Carcinoma In Situ
Carcinoma, Intraductal, Noninfiltrating
Carcinoma, Lobular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Carcinoma, Ductal
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary