Sentinel Lymph Node Mapping Post-Injection Site Pain

Breast Cancer Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02065232
• Other study ID #: SLNPain01
• Status: Completed
• Start date: March 2014
• Est. completion date: February 2015

Study information

• Verified date: August 2019
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Tilmanocept

• Sulfur Colloid

Locations

Country	Name	City	State
United States	University of California, San Diego	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	Navidea Biopharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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