Tilmanocept vs Sulfur Colloid in Sentinel Lymph Node Biopsy

NCT03199560 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2018-08-24

No results posted yet for this study

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

Conditions

Interventions

DRUG

Tc 99m tilmanocept

lymphatic mapping agent

DRUG

Tc 99m filtered sulfur colloid

lymphatic mapping agent

Sponsors & Collaborators

  • Memorial Health University Medical Center

    lead OTHER

Principal Investigators

  • William Burak, MD · Memorial Health University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-22
Primary Completion
2019-06-22
Completion
2019-08-22
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03199560 on ClinicalTrials.gov