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
1 other identifier
interventional
86
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jun 2017
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 22, 2017
CompletedFirst Submitted
Initial submission to the registry
June 23, 2017
CompletedFirst Posted
Study publicly available on registry
June 27, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 22, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 22, 2019
CompletedAugust 24, 2018
August 1, 2018
2 years
June 23, 2017
August 23, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Number of harvested lymph nodes
Looking for differences between the treatment arms in the number of harvest sentinel lymph nodes
1 day
Study Arms (2)
Tilmanocept
ACTIVE COMPARATORTc 99m tilmanocept
Sulfur Colloid
ACTIVE COMPARATORTc 99m filtered sulfur colloid
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Memorial Health University Medical Center
Savannah, Georgia, 31404, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
William Burak, MD
Memorial Health University Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Masking Details
- A double-blind study. Study compound will be masked before dispensing to care team.
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2017
First Posted
June 27, 2017
Study Start
June 22, 2017
Primary Completion
June 22, 2019
Study Completion
August 22, 2019
Last Updated
August 24, 2018
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will not share