Study Comparing Lymphoseek® vs. Albumin Nanocolloid in Head and Neck, Melanoma and Breast Cancer (SENTINELSEEK)

An Exploratory Prospective, Open-label, Unicentric Study With Cross-over Design, Comparing Lymphoseek® vs. Albumin Nanocolloid for Image- Guided Sentinel Lymph Node Mapping in Head and Neck, Melanoma and Breast Cancer.

Comparison of the concordance of albumin nanocolloid and Lymphoseek® in the detection of lymph nodes of primary and secondary stage drainage by performing two lymphogammagrams

Study Overview

• Status: Unknown
• Conditions: Melanoma; Breast Cancer; Head Cancer; Neck Cancer
• Intervention / Treatment: Drug: Lymphoseek; Drug: Nanocoll

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08036
    • Hospital Clínico y Provincial de Barcelona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Written informed consent
• Histologically confirmed diagnosis of melanoma, breast cancer or head and neck cancer and candidate for surgical resection with lymph node mapping being a part of the surgical plan.
• At least 18 years of age at the time of consent.
• The subject is clinically node negative (cN0) at the time of screening.

• In Melanoma Patients

  • Diagnosis of primary melanoma with sentinel node indication ( >0.8 mm Breslow thickness; clinically negative lymph nodes)

• In Breast Cancer Patients

  • T1-T2 N0 breast cancer.
  • Patients with pure ductal carcinoma in situ (DCIS) if lymph node biopsy is part of the surgical plan.

• In Oral cavity tumors patients

  • T1-T2 N0 oral cavity squamous cell carcinoma

Exclusion Criteria:

• Pregnancy or lactation
• Clinical or radiological evidence of metastatic cancer including palpably abnormal or enlarged lymph nodes
• Patients that have had preoperative chemotherapy, immunotherapy or radiation therapy
• Patients who have undergone node basin surgery of any type or radiation to the nodal basin(s) potentially draining the primary tumor
• Patients who have undergone a wide excision for their tumor or complex reconstruction (rotation, free flap or skin graft of any type).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Lymphoseek + Nanocoll; Comparison of the concordance of albumin nanocolloid and Lymphoseek® in the detection of lymph nodes of primary and secondary stage drainage by performing two lymphogammagrams	Drug: Lymphoseek; 50 μg microgram(s), timepoint: 30-60 minutes; Drug: Nanocoll; 500 μg microgram(s), timepoint: 30-60 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nodal Concordance: proportion of lymph nodes identified by 99mTc-tilmanocept vs nanocolloidal human serum albumin by lymphoscintigraphies	number and diameter in millimeters of nodes affected identified by 99mTc-tilmanocept vs nanocolloidal	for at least 48 consecutive hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time frame to ascertain the sentinel nodes		1 week
Concordance among early and delayed images obtained withLymphoseek® or with albumianocolloid and the SPECT/CT images.		1 week
Number of sentinel nodes and secondary nodes depicted		1 week
Tracer retention in injection site		1 week
Safety and tolerability of 99mTctilmanocept (Lymphoseek®)	Number of participants with treatment-related adverse events as assessed by Lymphoseek® or with albuminanocolloid	1 week

Collaborators and Investigators

• Sponsor: Anna Cruceta

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2020
• Primary Completion (Anticipated): February 1, 2021
• Study Completion (Anticipated): August 1, 2021

Study Registration Dates

• First Submitted: February 5, 2020
• First Submitted That Met QC Criteria: February 6, 2020
• First Posted (Actual): February 7, 2020

Study Record Updates

• Last Update Posted (Actual): February 20, 2020
• Last Update Submitted That Met QC Criteria: February 18, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Breast Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Breast Neoplasms; Head and Neck Neoplasms; Melanoma
• Other Study ID Numbers: 2019-003825-56

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No