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

February 13, 2014
February 14, 2014
February 2014
October 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT02065232 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Breast Cancer
  • Drug: Tilmanocept
    Other Name: Lymphoseek
  • Drug: Sulfur Colloid
  • Active Comparator: Tilmanocept
    Patients will receive technetium-labeled tilmanocept, which is FDA approved for sentinel lymph node mapping in breast cancer.
    Intervention: Drug: Tilmanocept
  • Active Comparator: Sulfur Colloid
    Patients will receive technetium-labeled sulfur colloid, which is FDA approved for sentinel lymph node mapping in breast cancer.
    Intervention: Drug: Sulfur Colloid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
52
October 2014
October 2014   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact: Anne Wallace, MD 858-822-6193 amwallace@ucsd.edu
Contact: Ava Hosseini, MD avhosseini@ucsd.edu
United States
 
NCT02065232
SLNPain01
No
Anne Wallace, MD, University of California, San Diego
University of California, San Diego
Navidea Biopharmaceuticals
Not Provided
University of California, San Diego
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP