Clinical trial · Interventional
Stereotactic Image-Guided Navigation During Breast Reconstruction in Patients With Breast Cancer
Intraoperative Stereotactic Image-guided Navigation of Perforators for DIEP Flap Breast Reconstruction.
- 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)
Many hospitals, including the Ohio State University Medical Center, will take pictures of the blood vessels in a patient's abdomen before they decide to perform a breast reconstruction using the patient's own tissue. These pictures are called computed tomography (CT) angiograms and are like a map of each patient's anatomy. However, no study has been reported that determined how accurate these pictures are at showing the surgeon where all of the blood vessels were located. This study will try to determine if these pictures are missing any blood vessels that are found during surgery and if the pictures show the correct location of the vessels
Conditions
Conditions (10)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ductal Breast Carcinoma in Situ | Breast Ductal Carcinoma In Situ | ALIAS | 0.90 |
| Lobular Breast Carcinoma in Situ | Breast Lobular Carcinoma In Situ | ALIAS | 0.90 |
| Recurrent Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IA Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IB Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage II Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIA Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| breast reconstruction | Procedure | — | UNRESOLVED |
| intraoperative imaging | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Supportive care (image-guided breast reconstruction)
- description
- Patients undergo DIEP flap breast reconstruction using the StealthStation navigation system.
- interventionNames
- Procedure: breast reconstruction
- Procedure: intraoperative imaging
Primary outcomes (2)
- measure
- The number of perforators that are found intraoperatively but not seen preoperatively on CT angiogram images
- timeFrame
- Up to 2 years
- measure
- Whether the preoperative CT angiography allowed the surgeon to accurately predict the perforator vessels that were actually used in the final flap design and transfer
- timeFrame
- Up to 2 years
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with histologically confirmed breast carcinoma or breast carcinoma in situ desiring unilateral or bilateral deep inferior epigastric perforator (DIEP) flap breast reconstruction * Patients must be candidates for elective surgery, without clinically significant cardiac or pulmonary disease (New York Heart Association \[NYHA\] class III/IV), without infection requiring antibiotics, and without serious illness requiring the use of steroids * Patients must have normal kidney function and no allergy to intravenous (IV) dye Exclusion Criteria: * Patients with previous abdominal donor site flaps will be excluded along with patients with previous extensive surgery to the anterior abdomen * Patients with a weight of over 300 pounds or a body size not supported by the CT scanner will be excluded * Patients who are expected to undergo postoperative radiation therapy will be excluded
References
Publications (0)
Data not yet available