Clinical trial · Interventional
3D Printed Breast Models in the Surgical Management of Breast Cancer
NCT05755984CI-TRIAL-00104218active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To learn if providing a 3-D printed model of the breast can help breast cancer patients make decisions related to their care. During this study, some study participants will receive the 3-D printed model and some study participants will receive traditional breast imaging scans to learn if the 3-D printed model
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3D printed model | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 1: 3D printed model
- description
- a 3-D printed model of your breast will be created and discussed with participants during your surgical consultation.
- interventionNames
- Diagnostic Test: 3D printed model
- type
- NO_INTERVENTION
- label
- Arm 2: No 3D printed model
- description
- Participants will have a standard-of-care surgical consultation using traditional breast imaging.
Primary outcomes (1)
- measure
- Decision Conflict Scale (DCS) score questionnaires
- timeFrame
- through study completion; an average of 1 year.
- description
- Score scale ranges: Strongly Agree 1, Agree 2 Neither agree or Agree 3 Strongly Disagree 4
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.