- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00671918
Trial of Lymphoseek in Intraoperative Localization of Lymph Nodes in Breast Cancer and Melanoma
A Phase 3, Prospective, Open-Label, Multicenter Comparison Study of Lymphoseek® and Vital Blue Dye as Lymphoid Tissue Targeting Agents in Patients With Known Melanoma or Breast Cancer Who Are Undergoing Lymph Node Mapping
Study Overview
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Tel Aviv, Israel, 64239
- Schlomo Schneebaum, M.D.
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Alabama
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Alexander City, Alabama, United States, 35010
- Barbara Michna, M.D
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Birmingham, Alabama, United States, 35294
- Helen Krontiras, M.D.
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California
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La Jolla, California, United States, 92093
- Anne Wallace, M.D.
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Laguna Hills, California, United States, 92653
- Ken Deck, M.D.
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Sacramento, California, United States, 95817
- Steve Martinez, M.D.
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Santa Monica, California, United States, 90404
- Mark Faries, M.D.
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Florida
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Miami, Florida, United States, 33101
- Eli Avisar, M.D.
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Tampa, Florida, United States, 33612
- Charles Cox, M.D.
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Tampa, Florida, United States, 33612
- Vernon Sondak, M.D.
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Ohio
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Cleveland, Ohio, United States, 44106
- Julian Kim, M.D.
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Cleveland, Ohio, United States, 44109
- Bruce Averbook, M.D
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Columbus, Ohio, United States, 43210
- Stephen Povoski, M.D.
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Pennsylvania
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Bryn Mawr, Pennsylvania, United States, 19010
- Thomas Frazier, M.D.
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Philadelphia, Pennsylvania, United States, 19096
- Ned Carp, M.D.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- The patient has provided written informed consent with HIPAA authorization 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 at least 18 years of age at the time of consent.
- The patient has an ECOG performance status of Grade 0 - 2 [8].
- The patient has a clinical negative node status at the time of study entry.
- If of child bearing potential, the patient has a negative pregnancy test within 72 hours prior to administration of Lymphoseek, has been surgically sterilized, or has been postmenopausal for at least 1 year.
- The patient is currently not participating in another investigational drug study.
Melanoma Patients
- The patient has a diagnosis of primary melanoma.
Breast Cancer Patients
- The patient has a diagnosis of primary breast cancer.
- Patients with pure ductal carcinoma in situ (DCIS) or non-invasive carcinoma if lymph node biopsy is part of the surgical plan.
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 (i.e., all patients should be any T,N0,M0);
- The patient has a known hypersensitivity to Lymphazurin or Patent Bleu V.
Melanoma Patients
- The patient has a tumor with a Breslow depth less than 0.75mm.;
- Patients that have had preoperative chemotherapy, immunotherapy or radiation therapy;
- Patients diagnosed with a prior invasive melanoma that would occur on the same body region or potentially draining to the same nodal basin or patients with truncal or extremity primary melanoma who has had a prior breast cancer potentially draining to the same axillary nodal basin;
- Patients who have undergone node basin surgery of any type or radiation to the nodal basin(s) potentially draining the primary melanoma;
- Patients who have undergone a wide excision for their primary melanoma (>1 cm in dimension) or complex reconstruction (rotation, free flap or skin graft of any type).
Breast Cancer Patients
- The patient has bilateral primary breast cancers or multiple tumors within their breast;
- Patients that have had prior surgical procedures such as breast implants, reduction mammoplasty or axillary surgery;
- Patients scheduled for bilateral mastectomy for any reason;
- Patients that have had preoperative radiation therapy to the affected breast or axilla
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lymphoseek, Lymphatic mapping, Injection
|
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Concordance of Blue Dye and Lymphoseek
Time Frame: Surgery after injections of Lymphoseek and blue dye
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The proportion of lymph nodes detected intraoperatively by blue dye that were also detected by Lymphoseek.
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Surgery after injections of Lymphoseek and blue dye
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reverse Concordance of Blue Dye and Lymphoseek
Time Frame: Surgery after injections of Lymphoseek and blue dye
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The proportion of lymph nodes detected intraoperatively by Lymphoseek that were also detected by blue dye.
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Surgery after injections of Lymphoseek and blue dye
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Richard Orahood, M.D., Navidea Biopharmaceuticals
Publications and helpful links
General Publications
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- Tsugawa K, Noguchi M, Miwa K, Bando E, Yokoyama K, Nakajima K, Michigishi T, Tonami N, Minato H, Nonomura A. Dye- and gamma probe-guided sentinel lymph node biopsy in breast cancer patients: using patent blue dye and technetium-99m-labeled human serum albumin. Breast Cancer. 2000 Jan;7(1):87-94. doi: 10.1007/BF02967195.
- Donahue EJ. Sentinel node imaging and biopsy in breast cancer patients. Am J Surg. 2001 Oct;182(4):426-8. doi: 10.1016/s0002-9610(01)00731-0.
- Martin RC, Derossis AM, Fey J, Yeung H, Yeh SD, Akhurst T, Heerdt AS, Petrek J, VanZee KJ, Montgomery LL, Borgen PI, Cody HS 3rd. Intradermal isotope injection is superior to intramammary in sentinel node biopsy for breast cancer. Surgery. 2001 Sep;130(3):432-8. doi: 10.1067/msy.2001.116412.
- Bauer TW, Spitz FR, Callans LS, Alavi A, Mick R, Weinstein SP, Bedrosian I, Fraker DL, Bauer TL, Czerniecki BJ. Subareolar and peritumoral injection identify similar sentinel nodes for breast cancer. Ann Surg Oncol. 2002 Mar;9(2):169-76. doi: 10.1007/BF02557370.
- Kern KA. Concordance and validation study of sentinel lymph node biopsy for breast cancer using subareolar injection of blue dye and technetium 99m sulfur colloid. J Am Coll Surg. 2002 Oct;195(4):467-75. doi: 10.1016/s1072-7515(02)01312-1.
- Tuttle TM, Colbert M, Christensen R, Ose KJ, Jones T, Wetherille R, Friedman J, Swenson K, McMasters KM. Subareolar injection of 99mTc facilitates sentinel lymph node identification. Ann Surg Oncol. 2002 Jan-Feb;9(1):77-81. doi: 10.1245/aso.2002.9.1.77.
- Zavagno G, Meggiolaro F, Rossi CR, Casara D, Pescarini L, Marchet A, Denetto V, Baratella P, Lise M. Subareolar injection for sentinel lymph node location in breast cancer. Eur J Surg Oncol. 2002 Nov;28(7):701-4. doi: 10.1053/ejso.2002.1340.
- Pelosi E, Bello M, Giors M, Ala A, Giani R, Bussone R, Bisi G. Sentinel lymph node detection in patients with early-stage breast cancer: comparison of periareolar and subdermal/peritumoral injection techniques. J Nucl Med. 2004 Feb;45(2):220-5.
- Wada N, Imoto S, Yamauchi C, Hasebe T, Ochiai A, Ebihara S. Correlation between concordance of tracers, order of harvest, and presence of metastases in sentinel lymph nodes with breast cancer. Ann Surg Oncol. 2005 Jun;12(6):497-503. doi: 10.1245/ASO.2005.07.013. Epub 2005 Apr 19.
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- Hodgson N, Zabel P, Mattar AG, Engel CJ, Girvan D, Holliday R. A new radiocolloid for sentinel node detection in breast cancer. Ann Surg Oncol. 2001 Mar;8(2):133-7. doi: 10.1007/s10434-001-0133-2.
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Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NEO3-05
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Navidea BiopharmaceuticalsActive, not recruitingRheumatoid ArthritisUnited States
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Cardinal Health 414, LLCTerminatedUterine Cervical NeoplasmsUnited States
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Navidea BiopharmaceuticalsNational Cancer Institute (NCI); National Institutes of Health (NIH)CompletedHIV Infections | Kaposi SarcomaUnited States
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Washington University School of MedicineLloyd J. Old STAR ProgramTerminatedCentral Nervous System Neoplasms | Central Nervous System TumorUnited States
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Navidea BiopharmaceuticalsCompletedRheumatoid ArthritisUnited States
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University of California, San DiegoNavidea BiopharmaceuticalsCompleted
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Navidea BiopharmaceuticalsRecruitingRheumatoid ArthritisUnited States, United Kingdom