Skip to main content
OpenTrials
Completed

NCT Number: NCT02065232

Sentinel Lymph Node Mapping Post-Injection Site Pain

This is a pain survey study that will compare the level of discomfort experienced by breast cancer patients after injection of either technetium-labeled sulfur colloid or technetium-labeled tilmanocept, both FDA-approved agents used for sentinel lymph node biopsy (SLNB). Breast cancer patients who are already scheduled for SLNB as part of their original surgical plan will be asked to participate in this study and be randomized to receive either technetium-labeled sulfur colloid or technetium-labeled tilmanocept. After injection, patients will complete pain questionnaires to measure the amount of discomfort they are feeling during and after they receive the injection. There will be no change to the patient's treatment plan other than the addition of pain questionnaires. The investigators' hypothesis is that patients will feel less discomfort after injection of tilmanocept versus sulfur colloid.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of California, San Diego

San Diego, California, 92093, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The patient has a diagnosis of biopsy-proven primary breast cancer or a diagnosis of pure ductal carcinoma in situ (DCIS) who will be undergoing intraoperative lymphatic mapping as part of their standard surgical plan.
  • The patient has provided written informed consent before participating in the study, as has his/her responsible caregiver, if applicable.
  • The patient is a candidate for surgical intervention, with lymph node mapping being a part of the surgical plan.
  • The patient is greater than 18 years of age at the time of consent.
  • The patient has an performance status of Grade 0 - 2.
  • The patient has a clinical negative node status at the time of study entry.
  • If the patients is of child bearing potential, the patient has a negative pregnancy test within 72 hours prior to administration of radiopharmaceutical, has been surgically sterilized, or has been postmenopausal for at least 1 year.

Exclusion criteria

  • The patient is pregnant or lactating.
  • The patient has clinical or radiological evidence of metastatic cancer including palpably abnormal or enlarged lymph nodes

Treatment and study plan

Tilmanocept

Drug

Other names: Lymphoseek

Sulfur Colloid

Drug

Primary outcomes

  1. Change from baseline level of discomfort

    Time frame: 1,2,3,4,5,15, 30 minutes after injection

    After injection of either tilmanocept or sulfur colloid, patients will be asked to fill out a pain questionnaire at the above time points.

Secondary outcomes

  1. Visualization of Sentinel Lymph Nodes on Lymphoscintigraphy

    Time frame: 15,30,60 minutes after injection

    After injection of sulfur colloid or tilmanocept, patients will undergo lymphoscintigraphy imaging (as is standard of care for sentinel lymph node mapping) at 5, 30, and 60 minutes. We will analyze the time it takes for sentinel lymph nodes to appear on these images comparing tilmanocept versus sulfur colloid.

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • Navidea Biopharmaceuticals

Registry information

Official study title

A Randomized, Double-blinded, Controlled Clinical Trial Comparing Post-injection Site Pain of Technetium-labeled Tilmanocept Versus Technetium-labeled Sulfur Colloid in Patients Undergoing Sentinel Lymph Node Mapping Procedure for Breast Cancer

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Feb 17, 2014
Registry last updated
Aug 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.