Clinical trial · Interventional
Tilmanocept vs Sulfur Colloid in Sentinel Lymph Node Biopsy
A Randomized Controlled Double-blinded Study Comparing the Intraoperative Injection of Lymphatic Mapping Agents Tc 99m Tilmanocept to Tc 99m Filtered Sulfur Colloid in Breast Cancer Patients Undergoing Breast Conservation and Sentinel Lymph Node Biopsy
NCT03199560CI-TRIAL-00034556unknownPhase 4ClinicalTrials.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)
A randomized controlled double-blinded study comparing the intraoperative injection of lymphatic mapping agents Tc 99m tilmanocept to Tc 99m filtered sulfur colloid in breast cancer patients undergoing breast conservation and sentinel lymph node biopsy
Conditions
Conditions (2)
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 |
| Sentinel Lymph Node Biopsy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tc 99m filtered sulfur colloid | Drug | — | UNRESOLVED |
| Tc 99m tilmanocept | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Tilmanocept
- description
- Tc 99m tilmanocept
- interventionNames
- Drug: Tc 99m tilmanocept
- type
- ACTIVE_COMPARATOR
- label
- Sulfur Colloid
- description
- Tc 99m filtered sulfur colloid
- interventionNames
- Drug: Tc 99m filtered sulfur colloid
Primary outcomes (1)
- measure
- Number of harvested lymph nodes
- timeFrame
- 1 day
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women above 18 years of age with biopsy proven, clinically stage 1 or 2 breast cancer who will be undergoing partial mastectomy with SLNBx at Memorial Health Exclusion Criteria: * Women under the age of 18, * Clinically positive axillary nodes * Neoadjuvant therapy for current breast cancer diagnosis * Women with previous SLNBx or axillary node dissection * Pregnant women * Women with previous radiation above the diaphragm, and below the neck
References
Publications (0)
Data not yet available
No reference posted for this study.