Clinical trial · Interventional
UHFUS Characterization of Normal Lymphatic Anatomy
Redefining the Normal: Ultra-High Frequency Ultrasound Characterization of Lymphatic Anatomy in Patients With Breast Cancer
NCT07677839CI-TRIAL-00116408UHFUSrecruitingN/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)
This is a prospective pilot study of breast cancer patients undergoing axillary lymph node dissection (ALND) or sentinel lymph node biopsy (SLNB). Participants will undergo ultra-high frequency ultrasound (UHFUS) imaging with indocyanine green (ICG) dye to map lymphatic channels between the wrist and elbow to investigate normal lymphatic anatomy in patients with 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Indocyanine green (ICG) solution injection | Procedure | — | UNRESOLVED |
| Ultra-High Frequency Ultrasound | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ultra-high frequency ultrasound (UHFUS) imaging with indocyanine green (ICG) dye
- description
- Indocyanine green (ICG) solution will be injected intradermally, followed by ultra-high-frequency ultrasound imaging/mapping to characterize lymphatic channels.
- interventionNames
- Procedure: Indocyanine green (ICG) solution injection
- Device: Ultra-High Frequency Ultrasound
Primary outcomes (1)
- measure
- Outer lymphatic vessel diameter
- timeFrame
- During ultra-high frequency ultrasound imaging
- description
- Total diameter including wall and lumen
Secondary outcomes (11)
- measure
- Vessel wall thickness
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 1\. Aged 18+ at the time of consent. * 2\. Confirmed breast cancer diagnosis * 3\. Planned ALND (CPT code: 38745) or SLNB (CPT code: 38900) for breast cancer treatment * 4\. Provision of a signed and dated informed consent form. * 5\. Stated willingness to comply with all study procedures and availability for the duration of the study. Exclusion Criteria: * 1\. History of transient or permanent edema of the extremity, including edema ≥stage 1 per the International Society of Lymphology (ISL) staging system 15 * 2\. History of prior axillary nodal surgery * 3\. History of any lymphatic disease or venous disease of the upper extremity, including deep venous thrombosis
References
Publications (0)
Data not yet available
No reference posted for this study.