Sentinel Lymph Node Mapping Post-Injection Site Pain

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Tilmanocept; Drug: Sulfur Colloid

• Study Type: Observational
• Enrollment (Actual): 52

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92093
      • University of California, San Diego

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Female patients, aged 18 years or older with a diagnosis of primary breast cancer or ductal carcinoma in situ (DCIS) with planned Sentinel node biopsy (SLN) biopsy as part of the surgical plan were approached at preoperative clinic visits of the principal investigator. (Anne Wallace)

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Tilmanocept; Patients will receive technetium-labeled tilmanocept, which is FDA approved for sentinel lymph node mapping in breast cancer.	Drug: Tilmanocept; Other Names: Lymphoseek
Sulfur Colloid; Patients will receive technetium-labeled sulfur colloid, which is FDA approved for sentinel lymph node mapping in breast cancer.	Drug: Sulfur Colloid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline level of discomfort	After injection of either tilmanocept or sulfur colloid, patients will be asked to fill out a pain questionnaire at the above time points.	1,2,3,4,5,15, 30 minutes after injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visualization of Sentinel Lymph Nodes on Lymphoscintigraphy	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.	15,30,60 minutes after injection

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Collaborators: Navidea Biopharmaceuticals

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (ACTUAL): February 1, 2015
• Study Completion (ACTUAL): February 1, 2015

Study Registration Dates

• First Submitted: February 13, 2014
• First Submitted That Met QC Criteria: February 14, 2014
• First Posted (ESTIMATE): February 17, 2014

Study Record Updates

• Last Update Posted (ACTUAL): August 14, 2019
• Last Update Submitted That Met QC Criteria: August 13, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: SLNPain01