A Phase 3 interventional study of Lymphoseek in Breast Cancer and Melanoma, sponsored by Navidea Biopharmaceuticals. Completed at 15 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-06-17.
Sponsored by Navidea Biopharmaceuticals · Phase 3, Interventional, and Treatment
Data from this pivotal clinical trial will be used to support a marketing application (i.e., NDA) for Navidea's Lymphoseek for use in intraoperative localization of lymph tissue (nodes) in the lymphatic pathway draining the primary site of a tumor.
In patients with primary melanoma and breast cancer, lymph node status is often a strong predictor of outcome and influences the course of treatment a patient may follow after surgery. In an effort to reduce the morbidity and costs of detection of lymph node metastases, surgical oncologists have developed a method by which the sentinel lymph node (the first node in a draining basin) is identified intraoperatively and removed. This technique, called sentinel node biopsy, has extremely high negative predictive values for melanoma metastases and breast cancer metastases. The two largest trials for melanoma, Morton, et al (2005) and Rossi, et al (2006), reported false negative rates of 6.3% and 14.7%, respectively. Morton, et al (2006), in perhaps the most mature trial reported to date, showed a false negative rate of 3.4% . There is growing evidence that sentinel node biopsy will have a significant impact on the management of melanoma. Sentinel node biopsy also has extremely high negative predictive values for breast cancer metastases; the false-negative rates range from 0% to 9%. There is growing evidence that sentinel node biopsy will have a significant impact on the management of breast cancer. Although the survival and local recurrence studies have yet to be completed, the technique has emerged into common practice.
Lymphatic mapping with a radiopharmaceutical is a nuclear medicine examination which identifies for the surgeon the first lymph node to receive lymphatic flow from the primary tumor site. This node is removed and analyzed for the presence of malignant cells. By locating the lymph node prior to surgery, a small incision can be used to remove the node and a smaller dissection can be employed. The high negative predictive value of the technique seems to provide an accurate staging procedure and may spare patients who are lymph node negative the morbidity of a complete lymph node dissection. Consequently, staging of melanoma by lymph node mapping and biopsy may be equivalent to regional node dissection without the attendant post surgical morbidity.
An ideal lymph node imaging agent would exhibit rapid clearance from the injection site, rapid uptake and high retention within the first draining lymph node, and low uptake by the remaining lymph nodes. The ideal agent would also have low radiation absorption; high biological safety; convenient, rapid, and stable technetium-99m labeling; and biochemical purity.
Lymphoseek (technetium-99m-labeled diethylenetriamine pentaacetic acid-mannosyl-dextran, [Tc-99m]DTPA-mannosyl-dextran) is a radiotracer that accumulates in lymphatic tissue by binding to a mannose-binding protein that resides on the surface of dendritic cells and macrophages. Lymphoseek is a macromolecule consisting of multiple units of DTPA and mannose, each synthetically attached to a 10 kilodalton dextran backbone. The mannose acts as a substrate for the receptor, and the DTPA serves as a chelating agent for labeling with Tc-99m.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 186 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Navidea Biopharmaceuticals is the lead sponsor of 19 studies on the registry; none are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 6 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Melanoma Patients
Breast Cancer Patients
Exclusion Criteria:
Melanoma Patients
Breast Cancer Patients
Drug: Lymphoseek
Breast Cancer: Intradermal admin of Lymphoseek: Inject 0.2-0.4 mL in multiple divided injections or a single injection overlying the intact primary tumor or excision biopsy site OR periareolar administration of Lymphoseek: Inject 0.2-.04 mL in multiple divided doses at the margin of the areola OR subareolar administration of Lymphoseek: Inject 0.2-0.4 in multiple divided injections or a single injection in subareolar area as a subcutaneous injection OR peritumor administration of Lymphoseek: Inject 2.0-4.0 mL in multiple divided injections, intraparenchemally surrounding the tumor or biopsy cavity. For melanoma pts intradermal administration of Lymphoseek: Inject 0.2-0.4 mL in multiple divided injections or a single injection overlying the intact primary tumor or excision biopsy site.
Also known as: technetium Tc 99m tilmanocept
Concordance of Blue Dye and Lymphoseek
The proportion of lymph nodes detected intraoperatively by blue dye that were also detected by Lymphoseek.
Time frame: Surgery after injections of Lymphoseek and blue dye
Reverse Concordance of Blue Dye and Lymphoseek
The proportion of lymph nodes detected intraoperatively by Lymphoseek that were also detected by blue dye.
Time frame: Surgery after injections of Lymphoseek and blue dye
| Milestone | Lymphoseek, Lymphatic Mapping, Injection |
|---|---|
| Started | 186 |
| Completed | 169 |
| Not completed | 17 |
The proportion of lymph nodes detected intraoperatively by blue dye that were also detected by Lymphoseek.
| Proportion of Lymph Nodes | Intent-To-Treat |
|---|---|
| Concordance of Blue Dye and Lymphoseek | 0.9767 (0.9466 to 0.9924) |
The proportion of lymph nodes detected intraoperatively by Lymphoseek that were also detected by blue dye.
| Proportion of Lymph Nodes | Reverse Intent-To-Treat |
|---|---|
| Reverse Concordance of Blue Dye and Lymphoseek | 0.6863 (0.6310 to 0.7379) |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Lymphoseek | — | 4/179 (2.2%) | 10/179 (5.6%) |
| Event | Lymphoseek |
|---|---|
| Myocardial InfarctionCardiac disorders | 1/179 |
| NauseaGastrointestinal disorders | 1/179 |
| VomitingGastrointestinal disorders | 1/179 |
| CellulitisInfections and infestations | 1/179 |
| Modified Radical MastectomySurgical and medical procedures | 1/179 |
| Event | Lymphoseek |
|---|---|
| NauseaGastrointestinal disorders | 10/179 |
Of the 186 participants who enrolled in the trial, 179 were administered the study agent, Lymphoseek, and therefore this participant number is used for the baseline analysis.
| Age, Categorical(Participants) | Lymphoseek |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 120 |
| >=65 years | 59 |
| Age Continuous(years) | Lymphoseek |
|---|---|
| Mean | 58.5 ± 14.1 |
| Sex: Female, Male(Participants) | Lymphoseek |
|---|---|
| Female | 128 |
| Male | 51 |
| Region of Enrollment(participants) | Lymphoseek |
|---|---|
| United States | 161 |
| Israel | 18 |
This study is completed, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.
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Navidea Biopharmaceuticals