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Free Flap Breast Reconstruction Using Virtual Surgical Planning and 3-D Modeling

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03949491
Recruitment Status : Not yet recruiting
First Posted : May 14, 2019
Last Update Posted : July 20, 2020
Sponsor:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

Brief Summary:
The purpose of this study is to determine if 3D modeling and Virtual Planning Surgery can improve the clinical outcome with patient who have a mastectomy requiring breast reconstruction.

Condition or disease Intervention/treatment Phase
Breast Reconstruction Procedure: 3D medical models Not Applicable

Detailed Description:

Primary objective: Using 3D medical models of the abdomen, a virtual plan will assist reconstruction to clearly define and 3D model the normal and aberrant vascular anatomy of the donor site in order to decrease dissection time and secondary perioperative complications including fat necrosis and donor site complications.

Secondary objective: To propose incision lines to match the corresponding volumetric analysis of the transposed tissue in order to facilitate the creation of a patient specific tailored flap, which will improve the aesthetic outcomes.

This is a single-armed, prospective study to determine the feasibility of using 3-D virtual planning and medical modeling in breast cancer patients undergoing breast reconstruction

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Free Flap Breast Reconstruction Using Virtual Surgical Planning and 3-D Modeling
Estimated Study Start Date : October 1, 2020
Estimated Primary Completion Date : February 28, 2021
Estimated Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 3-D virtual planning and medical modeling of breast

3-D virtual planning and medical modeling in breast cancer patients undergoing breast reconstruction.

  • Preoperative CT-Angiogram of the abdominal wall
  • Volumetric analysis preformed
  • 3D printed models made
  • Pre operative BREAST-Questionnaires given
  • Free tissue transfer performed: Operative/Dissection Time Recorded
  • Flap/Abdominal donor site complications recorded
  • Standard Digital Photography and Harris Scoring
  • BREAST-Questionnaires given at 3, 6 months
Procedure: 3D medical models
Using 3D medical models of the abdomen, a virtual plan will assist reconstruction to clearly define and 3D model the normal and aberrant vascular anatomy of the donor site in order to decrease both operative time and dissection time. This will also allow for the proposal of incision lines to match the corresponding volumetric analysis of the transposed tissue in order to facilitate the creation of a patient specific tailored flap, which will improve the aesthetic outcomes, decrease donor site complications and improve patient satisfaction




Primary Outcome Measures :
  1. Mean operative time [ Time Frame: Up to 6 months after reconstruction ]
    Mean operative time using 3D medical models of the abdomen to create a virtual plan to assist reconstruction.

  2. Mean dissection time [ Time Frame: Up to 6 months after reconstruction ]
    Mean dissection time using 3D medical models of the abdomen to create a virtual plan to assist reconstruction.


Secondary Outcome Measures :
  1. Aesthetic outcomes as measured by the Harris scale [ Time Frame: Up to 1 year after reconstruction ]
    Aesthetic outcomes as measured by the Harris scale, which ranges from 1-4, with higher scores indicating worse outcomes.

  2. Donor site complications [ Time Frame: Up to 1 year after reconstruction ]
    Number of donor site complications will be reported

  3. Incidence of fat necrosis as measured by a grading system [ Time Frame: 1 week, 2 weeks, 6 weeks, 3 months, and 6 months post reconstruction. ]

    Incidence of fat necrosis will be measured in the postoperative period using a classification system. Grade I necrosis will be defined as minimal requiring no surgical intervention; Grade II necrosis will be minor with some aesthetic defect requiring primary excision and closure; Grade III necrosis will be defined as requiring secondary procedures after excision to achieve satisfactory cosmesis; Grade IV necrosis will involve a necrosectomy requiring a either a completely new flap or at least a second flap to address such problems; Grade V necrosis will be defined as complete flap failure 5.

    Higher grade of fat necrosis is worse.


  4. Patient satisfaction as measured by BREAST-Q scores [ Time Frame: Up to 1 year after reconstruction ]
    Patient satisfaction as measured by BREAST-Q scores which ranges from 4-16, with higher scores indicating more satisfaction with breasts.



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects must have histologically or cytologically confirmed breast caner undergoing delayed or immediate breast reconstruction.
  • Performance statusECOG Performance status ≤ 2
  • Subjects must have normal organ and marrow function as defined below:
  • Hemoglobin ≥ 10.0 g/dl
  • Leukocytes ≥ 3,000/mcL
  • Absolute neutrophil count ≥ 1,500/mcL
  • Platelet count ≥ 100,000/mcL
  • Total bilirubin within normal institutional limits
  • AST (SGOT) ≤ 2.5 X institutional upper limit of normal
  • ALT (SGPT) ≤ 2.5 X institutional upper limit of normal
  • Serum Creatinine within normal institutional limits
  • Subjects must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Subjects receiving any prior abdominoplasty or abdominal liposuction, or patient that plan on undergoing radiation therapy after reconstruction.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to IV contrast.
  • Subjects with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Pregnant or breastfeeding women are excluded from this study because IV contrast and CT scans have the potential for teratogenic or abortifacient effects. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with breast cancer, breastfeeding should be discontinued.
  • Unsuitable donor site volume or vasculature based on pre-operative imaging or physical exam.

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): NCT03949491


Contacts
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Contact: Amir Ghaznavi 1-866-223-8100 TaussigResearch@ccf.org

Locations
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United States, Ohio
Cleveland Clinic, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195
Contact: Amir Ghaznavi    866-223-8100    TaussigResearch@ccf.org   
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
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Principal Investigator: Amir Ghaznavi The Cleveland Clinic
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Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT03949491    
Other Study ID Numbers: CASE6118
First Posted: May 14, 2019    Key Record Dates
Last Update Posted: July 20, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All IPD that underlie results in publication
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: at the conclusion of study and for 5 years
Access Criteria: data requestor will need to sign a data access agreement.
URL: http://redcap.ccf.org

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes