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

NCT01729832 | Withdrawn DMC

• 2 other identifiers: OSU-10106NCI-2012-00693
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

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

Outcome Measures

Primary Outcomes (2)

• The number of perforators that are found intraoperatively but not seen preoperatively on CT angiogram images

  Up to 2 years

• 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

  Up to 2 years

Secondary Outcomes (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

  Up to 2 years

Study Arms (1)

Supportive care (image-guided breast reconstruction)

EXPERIMENTAL

Patients undergo DIEP flap breast reconstruction using the StealthStation navigation system.

Procedure: breast reconstruction; Procedure: intraoperative imaging

Interventions

breast reconstruction PROCEDURE

Undergo DIEP flap breast reconstruction using the StealthStation navigation system

Also known as: Mammaplasty

Supportive care (image-guided breast reconstruction)

intraoperative imaging PROCEDURE

Undergo DIEP flap breast reconstruction using the StealthStation navigation system

Supportive care (image-guided breast reconstruction)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Related Links

• Jamesline

MeSH Terms

Conditions

Carcinoma, Intraductal, Noninfiltrating; Breast Carcinoma In Situ; Breast Neoplasms

Interventions

Mammaplasty

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cosmetic Techniques; Therapeutics; Plastic Surgery Procedures; Surgical Procedures, Operative

Study Officials

• Ergun Kocak, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 14, 2012
• First Posted: November 20, 2012
• Study Start: January 10, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: April 13, 2017

Record last verified: 2017-04