Sentinel Lymph Node Mapping Post-Injection Site Pain

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University of California, San Diego
Sponsor:
Collaborator:
Navidea Biopharmaceuticals
Information provided by (Responsible Party):
Anne Wallace, MD, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT02065232
First received: February 13, 2014
Last updated: February 14, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: Tilmanocept
Drug: Sulfur Colloid
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
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

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • Change from baseline level of discomfort [ Time Frame: 1,2,3,4,5,15, 30 minutes after injection ] [ Designated as safety issue: No ]
    After injection of either tilmanocept or sulfur colloid, patients will be asked to fill out a pain questionnaire at the above time points.


Secondary Outcome Measures:
  • Visualization of Sentinel Lymph Nodes on Lymphoscintigraphy [ Time Frame: 15,30,60 minutes after injection ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 52
Study Start Date: February 2014
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Tilmanocept
Patients will receive technetium-labeled tilmanocept, which is FDA approved for sentinel lymph node mapping in breast cancer.
Drug: Tilmanocept
Other Name: Lymphoseek
Active Comparator: Sulfur Colloid
Patients will receive technetium-labeled sulfur colloid, which is FDA approved for sentinel lymph node mapping in breast cancer.
Drug: Sulfur Colloid

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02065232

Contacts
Contact: Anne Wallace, MD 858-822-6193 amwallace@ucsd.edu
Contact: Ava Hosseini, MD avhosseini@ucsd.edu

Locations
United States, California
University of California, San Diego Recruiting
San Diego, California, United States, 92093
Contact: Anne Wallace, MD       amwallace@ucsd.edu   
Sponsors and Collaborators
University of California, San Diego
Navidea Biopharmaceuticals
  More Information

No publications provided

Responsible Party: Anne Wallace, MD, Professor of Clinical Surgery; Director of Breast Care Program, University of California, San Diego
ClinicalTrials.gov Identifier: NCT02065232     History of Changes
Other Study ID Numbers: SLNPain01
Study First Received: February 13, 2014
Last Updated: February 14, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on October 20, 2014