Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2024-09605 | Other Identifier | NCI-CTRP Clinical Trials Registry |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this study is to develop clinical decision-support algorithms for designing participants-specific breast molds for tissue shaping. Autologous breast reconstruction is an important part of breast cancer rehabilitation for many participants. Our goal is to increase the efficiency of autologous breast reconstruction by helping the surgeon design participants-specific molds for shaping tissue into an acceptable breast form.
Primary Objective:
To evaluate the efficiency of autologous reconstruction performed with 3D-printed participants-specific breast molds designed using our clinical decision-support algorithms.
Secondary Objectives:
To assess the total number of times the mold was used by the surgeons in the intervention group.
To compare the intraoperative time for shaping tissue in control versus intervention group.
To collect information on the type of revisions for aesthetic purposes required in control versus intervention group.
To assess the number and type of complications experienced in control versus intervention group.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intraoperative Use of 3D Printed Breast Mold | Experimental | Participants will be randomized using a 1:1 ration to 1 of 2 conditions |
|
| Standard of Care Reconstruction | Experimental | Participants will be randomized using a 1:1 ration to 1 of 2 conditions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard of care reconstruction | Procedure | Participants will receive standard of care reconstruction |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Adverse eEents (AEs) | Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 | Through study completion; an average of 1 year. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ashleigh M Francis, MD | Contact | 713-563-4598 | amfrancis@mdanderson.org |
| Name | Affiliation | Role |
|---|---|---|
| Ashleigh M Francis, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas M. D. Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
Not provided
| Label | URL |
|---|---|
| MD Anderson Cancer Center Website | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Surgery, Breast Mold | Procedure | Participants will undergo surgery. The surgeon may utilize the custom breast mold in shaping the autologous tissue flap for particiapnts. |
|