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| Name | Class |
|---|---|
| Navidea Biopharmaceuticals | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tilmanocept | Patients will receive technetium-labeled tilmanocept, which is FDA approved for sentinel lymph node mapping in breast cancer. |
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| Sulfur Colloid | Patients will receive technetium-labeled sulfur colloid, which is FDA approved for sentinel lymph node mapping in breast cancer. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tilmanocept | Drug |
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| Sulfur Colloid |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Visualization of Sentinel Lymph Nodes on Lymphoscintigraphy | 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. | 15,30,60 minutes after injection |
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Inclusion Criteria:
Exclusion Criteria:
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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)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Diego | San Diego | California | 92093 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C431884 | technetium-diethylenetriaminepentaacetic acid-mannosyl-dextran |
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| Drug |
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| D017437 |
| Skin and Connective Tissue Diseases |