Clinical trial · Observational
Prospective Radiologic Evaluation of Changes Following Fat Grafting
Prospective Radiologic Evaluation of Changes That Might Affect Breast Cancer Diagnosis Following Fat Grafting and Silicone Breast Implants
- 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)
Breast implants are currently used for cosmetic breast augmentation and in breast reconstruction following mastectomy for breast cancer. Fat grafting is a technique where fat is injected around the periphery of a breast implant to camouflage the transition between implant and the body. The investigators propose to show mammography images of women who have had breast implants with fat grafting to informed and blinded radiologists and evaluate their readings of the images. Hypothesis: with mammographic screening, radiologists will be able to distinguish between findings associated with fat grafting and those which are suspicious for breast cancer.
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 (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Patients with implants
- description
- Patients with silicone implants and fat grafting.
Primary outcomes (1)
- measure
- Radiologist dictations of mammograms
- timeFrame
- We will obtain mammograms and MRIs of participants at intervals of 6 months for up to 24 months post fat grafting.
- description
- We will compare the Bi-Rad level score readings, and recommended follow-up of the blinded and non-blinded radiologist's read of study participants mammograms.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 84 Years
Show eligibility criteria text
Inclusion Criteria: * Women with silicone implants and fat grafting Exclusion Criteria: * Procedures performed outside the University of Minnesota or Clinique Spontini Paris, France
References
Publications (0)
Data not yet available