Using 3D printed breast models to help breast cancer patients make treatment decisions
3D Printed Breast Models in the Surgical Management of Breast Cancer
This study is testing if 3D printed breast models can help breast cancer patients make better treatment decisions compared to regular 2D images.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT05755984 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of 3D printed breast models in assisting breast cancer patients with their treatment decisions compared to traditional 2D imaging. Participants will be randomly assigned to receive either a 3D printed model or standard imaging to assess their decisional conflict regarding surgical options. The study will also examine changes in patients' preferred surgical choices, the quality of communication with healthcare providers, surgical outcomes, and overall patient satisfaction post-surgery. The research is being conducted at the M.D. Anderson Cancer Center in Houston, Texas.
Who should consider this trial
Good fit: Ideal candidates are females aged 18 or older with histologically confirmed breast cancer who are candidates for surgical management.
Not a fit: Patients who are pregnant, breastfeeding, or have a history of mastectomy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance patient understanding and satisfaction in making informed decisions about their breast cancer treatment.
How similar studies have performed: While the use of 3D printed models in medical decision-making is a growing field, this specific application in breast cancer treatment decision-making is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 or older female * Patient must have histologically confirmed breast malignancy * Patient is a candidate for surgical management * Patient has a surgeon at MDACC (main campus and/or Houston Area Locations) * Patient has a breast MRI for extent of disease assessment at MDACC (main campus and/or Houston Area Locations). * Patient is able to speak, read or write English * Patient is willing to be randomized to the control or 3D printed breast model groups and is willing to sign the consent form. Exclusion Criteria: * Pregnant and breastfeeding patients * Patients who had history of mastectomy, have recurrent malignancies on the mastectomy side * Patients for whom it is not feasible to create a 3D printed breast model from breast MRI
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Lauren Chang Sen, MD — M.D. Anderson Cancer Center
- Study coordinator: Lauren Chang Sen, MD
- Email: lqchang@mdanderson.org
- Phone: (713) 745-4555
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.