Clinical trial · Interventional
An Investigational Surgical Procedure (Vascularized Lymph Node Transfer) in Reducing the Risk of Lymphedema in Patients With Breast Cancer Undergoing Breast Reconstruction
Assessment of Outcomes Following Prophylactic Lymph Node Transfer in Patients Undergoing Autologous 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)
This trial studies how an investigational surgical procedure called vascularized lymph node transfer works in lowering the risk of arm swelling (lymphedema) in patients with breast cancer undergoing breast reconstruction. Patients who undergo breast reconstruction are often at high risk of developing lymphedema. Vascularized lymph node transfer involves transferring lymph nodes from an unaffected area of the body to replace those removed as part of treatment, which may lower the risk of lymphedema after breast reconstruction.
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 Carcinoma | Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mammoplasty | Procedure | — | UNRESOLVED |
| Vascularized Lymph Node Transfer | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (vascularized lymph node transfer)
- description
- Patients undergo vascularized lymph node transfer during standard of care breast reconstructive surgery.
- interventionNames
- Procedure: Mammoplasty
- Procedure: Vascularized Lymph Node Transfer
Primary outcomes (2)
- measure
- Incidence rate of lymphedema development
- timeFrame
- At 12 months after surgery
- description
- Summary statistics such as means, standard deviations, median and range for continuous variables, and frequencies and percentages for categorical variables will be reported. The rate of lymphedema and its 95% exact confidence interval will be estimated.
- measure
- Time to lymphedema development
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients who have undergone treatment (mastectomy, axillary lymph node dissection \[ALND\], radiation and chemotherapy) for breast cancer and are seeking breast reconstruction Exclusion Criteria: * Patients that are known to be pregnant at the time of surgery * Patients with a known hypersensitivity to indocyanine green (ICG) and/or isosulfan blue (Lymphazurin)
References
Publications (0)
Data not yet available