Clinical trial · Interventional
Sentinel and/or Axillary Lymph Node Biopsy With or Without Axillary Reverse Mapping in Reducing Incidence and Severity of Arm Lymphedema in Stage 0-2 Patients.
Reducing the Incidence and Severity of Arm Lymphedema With Axillary Reverse Mapping and Implementation of a Lymphedema Screening and Intervention Program
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): P.I. left
Summary
Brief summary (as posted)
Lymph node biopsy followed by axillary reverse mapping may reduce the incidence and severity of arm lymphedema. This randomized phase II trial is studying how well sentinel and/or axillary lymph node biopsy with or without axillary reverse mapping works in reducing incidence and severity of lymphedema in patients with resectable stage 0-II breast cancer
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphedema | — | UNRESOLVED | — |
| 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 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| axillary lymph node biopsy | Procedure | — | UNRESOLVED |
| bioimpedance spectroscopy | Procedure | — | UNRESOLVED |
| indocyanine green solution | Drug | — | UNRESOLVED |
| lymphedema management | Other | — | UNRESOLVED |
| methylene blue | Drug | — | UNRESOLVED |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
| sentinel lymph node biopsy | Procedure | — | UNRESOLVED |
| technetium Tc 99m sulfur colloid | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SNB plus ARM or ALND (+/- SNB) plus ARM
- description
- Patients undergo sentinel lymph node biopsy (SNB) and/or axillary lymph node biopsy (ALND) using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node. Patients then undergo an axillary reverse mapping.
- interventionNames
- Radiation: technetium Tc 99m sulfur colloid
- Drug: methylene blue
- Drug: indocyanine green solution
- Procedure: sentinel lymph node biopsy
- Procedure: axillary lymph node biopsy
- Procedure: bioimpedance spectroscopy
- Procedure: quality-of-life assessment
- Other: lymphedema management
- type
- ACTIVE_COMPARATOR
- label
- SNB or ALND (+/- SNB)
- description
- Patients undergo SNB and/or ALND using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Stage 0, I, and II Breast Cancer * Not pregnant or breastfeeding * Breast cancer or prophylactic mastectomy requiring axillary nodal staging * Ability to read and/or comprehend consent form and questionnaires * Ability to follow-up per protocol * Unilateral axillary staging Exclusion Criteria: * Stage 3 * Previous axillary lymph node dissection * Neoadjuvant chemotherapy or hormonal therapy exceeding greater than 30 days duration * Allergy to blue dyes or iodine; NOTE: a non-blue dye or non-iodine-containing dye may be used in these patients * Patients with implanted medical devices such as a pacemaker may undergo perometry, but not BIS (Bioelectrical Impedance Spectroscopy) * Previous diagnosis of LE (lymphedema) of either extremity * Bilateral axillary staging
References
Publications (0)
Data not yet available