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Tilmanocept vs Sulfur Colloid in Sentinel Lymph Node Biopsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03199560
Recruitment Status : Recruiting
First Posted : June 27, 2017
Last Update Posted : August 24, 2018
Information provided by (Responsible Party):
Memorial Health University Medical Center

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

Condition or disease Intervention/treatment Phase
Sentinel Lymph Node Biopsy Breast Cancer Drug: Tc 99m tilmanocept Drug: Tc 99m filtered sulfur colloid Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: double-blinded randomized control trial
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: A double-blind study. Study compound will be masked before dispensing to care team.
Primary Purpose: Diagnostic
Official Title: 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
Actual Study Start Date : June 22, 2017
Estimated Primary Completion Date : June 22, 2019
Estimated Study Completion Date : August 22, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
Active Comparator: Tilmanocept
Tc 99m tilmanocept
Drug: Tc 99m tilmanocept
lymphatic mapping agent
Other Name: LymphoSeek

Active Comparator: Sulfur Colloid
Tc 99m filtered sulfur colloid
Drug: Tc 99m filtered sulfur colloid
lymphatic mapping agent

Primary Outcome Measures :
  1. Number of harvested lymph nodes [ Time Frame: 1 day ]
    Looking for differences between the treatment arms in the number of harvest sentinel lymph nodes

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03199560

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Contact: William Burak, MD 9123502700
Contact: Samuel Corey, MD 9123502700

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United States, Georgia
Memorial Health University Medical Center Recruiting
Savannah, Georgia, United States, 31404
Contact: William Burak, MD    912-350-2700   
Sponsors and Collaborators
Memorial Health University Medical Center
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Principal Investigator: William Burak, MD Memorial Health University Medical Center

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Responsible Party: Memorial Health University Medical Center Identifier: NCT03199560     History of Changes
Other Study ID Numbers: 2016.12.1
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases