Sentinel Lymph Node Mapping Post-Injection Site Pain

NCT ID: NCT02065232

Last Updated: 2019-08-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 52 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2015-02-28

Brief 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.

Conditions

Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Tilmanocept

Patients will receive technetium-labeled tilmanocept, which is FDA approved for sentinel lymph node mapping in breast cancer.

Tilmanocept

Intervention Type: DRUG

Sulfur Colloid

Patients will receive technetium-labeled sulfur colloid, which is FDA approved for sentinel lymph node mapping in breast cancer.

Sulfur Colloid

Intervention Type: DRUG

Interventions

Tilmanocept

Intervention Type: DRUG

Sulfur Colloid

Intervention Type: DRUG

Other Intervention Names

Lymphoseek

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Navidea Biopharmaceuticals

INDUSTRY

Sponsor Role: collaborator

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of California, San Diego

San Diego, California, United States

Countries

United States

Other Identifiers

SLNPain01

Identifier Type: -

Identifier Source: org_study_id