Clinical trial NCT03949491: Free Flap Breast Reconstruction Using Virtual Surgical Planning and 3-D Modeling
Official title: Free Flap Breast Reconstruction Using Virtual Surgical Planning and 3-D Modeling
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Reconstruction
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2019-05-14
Enrollment: 38
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Eligibility 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.

Primary outcomes:
measure: Mean operative time
timeFrame: Up to 6 months after reconstruction
measure: Mean dissection time
timeFrame: Up to 6 months after reconstruction
Secondary outcomes:
measure: Aesthetic outcomes as measured by the Harris scale
timeFrame: Up to 1 year after reconstruction
measure: Donor site complications
timeFrame: Up to 1 year after reconstruction
measure: Incidence of fat necrosis as measured by a grading system
timeFrame: 1 week, 2 weeks, 6 weeks, 3 months, and 6 months post reconstruction.
measure: Patient satisfaction as measured by BREAST-Q scores
timeFrame: Up to 1 year after reconstruction
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Amir Ghaznavi
role: PRINCIPAL_INVESTIGATOR
References: