Recruiting

Tilmanocept vs. Sulfur Colloid

Sponsor:

Memorial Health University Medical Center

Code:

NCT03199560

Conditions

Sentinel Lymph Node Biopsy

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tc 99m tilmanocept

Tc 99m filtered sulfur colloid

Study Details

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

Conditions

Sentinel Lymph Node Biopsy

Breast Cancer

Study ID

NCT03199560

Start date

Jun 22, 2017

Status verified date

Aug, 2018

Completion date

Aug 22, 2019

Anticipated

Primary completion date

Jun 22, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

86 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

active comparator: Tilmanocept

Tc 99m tilmanocept

active comparator: Sulfur Colloid

Tc 99m filtered sulfur colloid

Interventions

Tc 99m tilmanocept

lymphatic mapping agent

Tc 99m filtered sulfur colloid

lymphatic mapping agent

Primary outcome measure

  • Number of harvested lymph nodes [ Time Frame: 1 day ]

Central Contacts and Locations

Central contacts

William Burak, MD

9123502700CoreySa1@memorialhealth.com

Samuel Corey, MD

9123502700CoreySa1@memorialhealth.com

Locations

Memorial Health University Medical Center

Recruiting

Savannah, Georgia, United States, 31404

Contacts

William Burak, MD

912-350-2700CoreySa1@memorialhealth.com

More Information

Sponsor

Memorial Health University Medical Center

Last update posted

Aug 24, 2018

Last verified

Aug, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Health University Medical Center on 2018-08-24.