Sentinel Lymph Node Mapping Post-Injection Site Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02065232
Recruitment Status : Completed
First Posted : February 17, 2014
Last Update Posted : July 27, 2015
Navidea Biopharmaceuticals
Information provided by (Responsible Party):
Anne Wallace, MD, University of California, San Diego

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Tilmanocept Drug: Sulfur Colloid Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : March 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02065232

United States, California
University of California, San Diego
San Diego, California, United States, 92093
Sponsors and Collaborators
University of California, San Diego
Navidea Biopharmaceuticals

Responsible Party: Anne Wallace, MD, Professor of Clinical Surgery; Director of Breast Care Program, University of California, San Diego Identifier: NCT02065232     History of Changes
Other Study ID Numbers: SLNPain01
First Posted: February 17, 2014    Key Record Dates
Last Update Posted: July 27, 2015
Last Verified: July 2015

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