3D-Modeled Surgery for Breast Reconstruction

N/A

Waitlist Available

Led By Amir Ghaznavi

Research Sponsored by Case Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months after reconstruction

Awards & highlights

No Placebo-Only Group

Summary

This trial will study if using 3D models and Virtual Planning Surgery can improve outcomes for patients who need a mastectomy and breast reconstruction.

Who is the study for?

This trial is for individuals with confirmed breast cancer who need breast reconstruction after a mastectomy. They should be relatively healthy, with good organ function and blood counts within specific ranges. Participants must understand and agree to the study by signing consent forms. It's not for those who've had certain abdominal procedures, plan on radiation post-reconstruction, have severe illnesses or are pregnant/breastfeeding.

What is being tested?

The study is testing if using Virtual Surgical Planning (VSP) and 3D medical models can improve outcomes in breast reconstruction surgery following a mastectomy. The goal is to see whether these advanced planning tools lead to better surgical results compared to standard methods.

What are the potential side effects?

While the trial focuses on surgical outcomes rather than medication side effects, potential risks may include reactions related to IV contrast used in imaging or complications from surgery such as infection or issues with wound healing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months after reconstruction

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months after reconstruction

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months after reconstruction for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean dissection time

Mean operative time

Secondary study objectives

Aesthetic outcomes as measured by the Harris scale

Donor site complications

Incidence of fat necrosis as measured by a grading system

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: 3-D virtual planning and medical modeling of breastExperimental Treatment1 Intervention

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

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