Sentinel Lymph Node Mapping Post-Injection Site Pain

NCT02065232 | Completed

• 1 other identifier: SLNPain01
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Visualization of Sentinel Lymph Nodes on Lymphoscintigraphy

  15,30,60 minutes after injection

Study Arms (2)

Tilmanocept

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

Drug: Tilmanocept

Sulfur Colloid

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

Drug: Sulfur Colloid

Interventions

Tilmanocept DRUG

Also known as: Lymphoseek

Tilmanocept

Sulfur Colloid DRUG

Sulfur Colloid

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Female patients, aged 18 years or older with a diagnosis of primary breast cancer or ductal carcinoma in situ (DCIS) with planned Sentinel node biopsy (SLN) biopsy as part of the surgical plan were approached at preoperative clinic visits of the principal investigator. (Anne Wallace)

You may qualify if:

• 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.

You may not qualify if:

• The patient is pregnant or lactating.
• The patient has clinical or radiological evidence of metastatic cancer including palpably abnormal or enlarged lymph nodes

Sponsors & Collaborators

• University of California, San Diego: lead
• Navidea Biopharmaceuticals: collaborator

Study Sites (1)

University of California, San Diego

San Diego, California, 92093, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

technetium-diethylenetriaminepentaacetic acid-mannosyl-dextran

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2014
• First Posted: February 17, 2014
• Study Start: March 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: August 14, 2019

Record last verified: 2019-08

Locations

US (1)