Lymphoseek: A Molecular Imaging Agent for Melanoma Sentinel Lymph Node Mapping

Wallace, Anne M.; Hoh, Carl K.; Ellner, Scott J.; Darrah, Denise D.; Schulteis, Gery; Vera, David R.

doi:10.1245/s10434-006-9099-4

Cited by 76 publications

(55 citation statements)

References 7 publications

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“…Contrary to our expectation, the intradermal administration did not exhibit a faster clearance half-life (2.62 +/− 0.55 hr) than Phase I study group that utilized a periturmoral/intradermal injection [13], which exhibited a clearance half-life of 2.72 +/− 1.57 hr. This was also true for our melanoma study [12], where the measured clearance half-life was 2.05 +/− 0.89 hr. One noticeable difference between the three studies was the wide dispersion of clearance half-lives exhibited by the periturmoral/intradermal injections; this was denoted by relative standard deviation of 0.58, which is almost threefold greater than the relative standard deviation of the intradermal injection (0.21).…”

Section: Discussionsupporting

confidence: 73%

“…No adverse events or clinically significant changes in clinical and laboratory values were observed. These findings were also demonstrated at the 5-nmole dose level [1] and by patients with melanoma [12].…”

Section: Introductionsupporting

confidence: 55%

“…The mean sentinel lymph node accumulation after a 1-nmole dose of Lymphoseek using a standard mapping protocol for SLN of melanoma [12] was 0.49 ± 0.59 percent of injected dose. A breast cancer mapping protocol using an intradermal/periturmoral administration of Lymphoseek [13] yielded mean SLN uptakes of 0.55 ± 0.43 %.…”

Section: Discussionmentioning

confidence: 99%

“…This study used the same Lymphoseek preparation as our Phase I Breast cancer [1,13] and melanoma trials [12]. The mean molecular diameter was 7.0 nanometers and the average molecular weight was 28,200 grams per mole.…”

Section: Agent Preparationmentioning

confidence: 99%

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Sentinel lymph node mapping of breast cancer via intradermal administration of Lymphoseek

Wallace

Hoh

Darrah

et al. 2007

Nuclear Medicine and Biology

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Lymphoseek™ is a molecular imaging agent specifically designed for sentinel lymph node (SLN) mapping. We conducted a Phase I trial which measured the injection site clearance and sentinel lymph node accumulation after a single intra-dermal injection of Lymphoseek or [ 99m Tc]sulfur colloid protocol. Ten patients with breast cancer participated in this study. Five patients received an intradermal administration of 1.0 nmole of 99m Tc-labeled Lymphoseek and five patients received an intra-dermal administration of filtered [ 99m Tc]sulfur colloid (fTcSC). Lymphoseek, exhibited a significantly (P < .001) faster injection site clearance than fTcSC. The mean Lymphoseek clearance half-time was 2.61 ± 0.72 hr compared to 24.1 ± 17.7 hr for fTcSC. The mean sentinel lymph node uptake of Lymphoseek (1.1 ± .5%), and TcSC (2.5 ± 4.9%) were statistically equivalent (P = 0.28). When an intra-dermal injection was employed, Lymphoseek demonstrated faster injection site clearance than filtered [ 99m Tc]sulfur colloid.

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Section: Discussionsupporting

confidence: 73%

Section: Introductionsupporting

confidence: 55%

Section: Discussionmentioning

confidence: 99%

Section: Agent Preparationmentioning

confidence: 99%

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Sentinel lymph node mapping of breast cancer via intradermal administration of Lymphoseek

Wallace

Hoh

Darrah

et al. 2007

Nuclear Medicine and Biology

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“…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 distal lymph nodes (7). The commonly used agents-unfiltered or filtered 99m Tc-SC, albumin-based colloids, and 99m Tc-antimony trisulfide colloid-do not exhibit all these characteristics.…”

Section: The Ideal Radiotracermentioning

confidence: 99%

99mTc-Tilmanocept: A Novel Molecular Agent for Lymphatic Mapping and Sentinel Lymph Node Localization

Surasi

O’Malley

Bhambhvani

2015

Journal of Nuclear Medicine Technology

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AlabamaCE credit: For CE credit, you can access the test for this article, as well as additional JNMT CE tests, online at https://www.snmmilearningcenter.org. Complete the test online no later than June 2018. Your online test will be scored immediately. You may make 3 attempts to pass the test and must answer 80% of the questions correctly to receive 1.0 CEH (Continuing Education Hour) credit. SNMMI members will have their CEH credit added to their VOICE transcript automatically; nonmembers will be able to print out a CE certificate upon successfully completing the test. The online test is free to SNMMI members; nonmembers must pay $15.00 by credit card when logging onto the website to take the test.Preoperative lymphatic mapping in conjunction with intraoperative γ-probe detection is widely used for sentinel node localization in melanoma, breast cancer, and other malignancies. 99m Tc-radiocolloids have been the standard radiotracers used for sentinel node mapping. 99m Tc-tilmanocept is a receptorbinding molecular imaging agent approved by the U.S. Food and Drug Administration for lymphatic mapping and lymph node localization in breast cancer, melanoma, clinically nodenegative squamous cell carcinoma of the oral cavity, and other solid tumors. It has several advantages over conventional radiocolloids, including rapid injection site clearance, high sentinel node extraction, and low distal node accumulation, which can lead to efficient resource use.

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Use of a Novel Receptor-Targeted (CD206) Radiotracer,^99mTc-Tilmanocept, and SPECT/CT for Sentinel Lymph Node Detection in Oral Cavity Squamous Cell Carcinoma

Marcinow

Hall

Byrum

et al. 2013

JAMA Otolaryngol Head Neck Surg

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IMPORTANCE Sentinel lymph node biopsy has been proposed as an alternative to up-front elective neck dissection (END) for determination of pathologic nodal status in patients undergoing surgical treatment for oral cavity squamous cell carcinoma (OSCC) with clinically negative neck (cN0). Sentinel lymph node biopsy using current standard tracer agents and imaging adjuncts such as radiolabeled sulfur-colloid and planar lymphoscintigraphy (LS), however, is associated with several drawbacks. OBJECTIVE To assess the preliminary utility of technetium Tc 99m(99mTc)-tilmanocept, a novel molecular imaging agent for sentinel lymph node (SLN) mapping, in OSCC. DESIGN, SETTING, AND PARTICIPANTS Prospective, nonrandomized, single-arm, part of an ongoing phase 3 clinical trial. Patients had previously untreated, clinically and radiographically node-negative OSCC (T1-4aN0M0) at an academic tertiary referral center. INTERVENTIONS Patients received a single dose of 50 μg 99mTc-tilmanocept injected peritumorally followed by dynamic planar LS and fused single-photon emission computed tomography/computed tomography (SPECT/CT) prior to surgery. Surgical intervention consisted of excision of the primary tumor and radioguided SLN dissection followed by planned END. The excised lymph nodes (SLNs and non-SLNs) underwent histopathologic evaluation for presence of metastatic disease. MAIN OUTCOMES AND MEASURES False-negative rate and negative predictive value of SLNB using 99mTc-tilmanocept and comparison of planar LS with SPECT/CT in SLN localization. RESULTS Twelve of 20 patients (60%) had metastatic neck disease on pathologic examination. All 12 had at least 1 SLN positive for metastases. No patients had a positive END node who did not have at least 1 positive SLN. These data yield a false-negative rate of 0% and negative predictive value of 100% using 99mTc-tilmanocept in this setting. Dynamic planar LS and SPECT/CT revealed a mean (range) number of hot spots per patient of 2.9 (1-7) and 3.7 (1-12), respectively. Compared with planar LS, SPECT/CT identified additional putative SLNs in 11 of 20 cases (55%). CONCLUSIONS AND RELEVANCE The high negative predictive value and low false-negative rate in identification of occult metastases shows 99mTc-tilmanocept to be a promising agent in SLN identification in patients with OSCC. Use of SPECT/CT improves preoperative SLN localization including delineation of SLN locations near the primary tumor when compared with planar LS imaging. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00911326

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Lymphoseek: A Molecular Imaging Agent for Melanoma Sentinel Lymph Node Mapping

Abstract: The molecular imaging agent Lymphoseek demonstrated faster injection site clearance and equivalent primary sentinel node uptake when compared with filtered [(99m)Tc]sulfur colloid.

Cited by 76 publications

References 7 publications

Sentinel lymph node mapping of breast cancer via intradermal administration of Lymphoseek

Sentinel lymph node mapping of breast cancer via intradermal administration of Lymphoseek

99mTc-Tilmanocept: A Novel Molecular Agent for Lymphatic Mapping and Sentinel Lymph Node Localization

Use of a Novel Receptor-Targeted (CD206) Radiotracer,^99mTc-Tilmanocept, and SPECT/CT for Sentinel Lymph Node Detection in Oral Cavity Squamous Cell Carcinoma

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Lymphoseek: A Molecular Imaging Agent for Melanoma Sentinel Lymph Node Mapping

Abstract: The molecular imaging agent Lymphoseek demonstrated faster injection site clearance and equivalent primary sentinel node uptake when compared with filtered [(99m)Tc]sulfur colloid.

Cited by 76 publications

References 7 publications

Sentinel lymph node mapping of breast cancer via intradermal administration of Lymphoseek

Sentinel lymph node mapping of breast cancer via intradermal administration of Lymphoseek

99mTc-Tilmanocept: A Novel Molecular Agent for Lymphatic Mapping and Sentinel Lymph Node Localization

Use of a Novel Receptor-Targeted (CD206) Radiotracer,99mTc-Tilmanocept, and SPECT/CT for Sentinel Lymph Node Detection in Oral Cavity Squamous Cell Carcinoma

Contact Info

Product

Resources

About

Use of a Novel Receptor-Targeted (CD206) Radiotracer,^99mTc-Tilmanocept, and SPECT/CT for Sentinel Lymph Node Detection in Oral Cavity Squamous Cell Carcinoma