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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Change from baseline level of discomfort
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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 -
- •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.
排除标准
- •The patient is pregnant or lactating.
- •The patient has clinical or radiological evidence of metastatic cancer including palpably abnormal or enlarged lymph nodes
研究组 & 干预措施
Tilmanocept
Patients will receive technetium-labeled tilmanocept, which is FDA approved for sentinel lymph node mapping in breast cancer.
干预措施: Tilmanocept (Drug)
Sulfur Colloid
Patients will receive technetium-labeled sulfur colloid, which is FDA approved for sentinel lymph node mapping in breast cancer.
干预措施: Sulfur Colloid (Drug)
结局指标
主要结局
Change from baseline level of discomfort
时间窗: 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.
次要结局
- Visualization of Sentinel Lymph Nodes on Lymphoscintigraphy(15,30,60 minutes after injection)