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

February 18, 2020 updated by: Anna Cruceta

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: for at least 48 consecutive hours
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
Time Frame: 1 week
1 week
Concordance among early and delayed images obtained withLymphoseek® or with albumianocolloid and the SPECT/CT images.
Time Frame: 1 week
1 week
Number of sentinel nodes and secondary nodes depicted
Time Frame: 1 week
1 week
Tracer retention in injection site
Time Frame: 1 week
1 week
Safety and tolerability of 99mTctilmanocept (Lymphoseek®)
Time Frame: 1 week
Number of participants with treatment-related adverse events as assessed by Lymphoseek® or with albuminanocolloid
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anna Cruceta

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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