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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04261179
Recruitment Status : Not yet recruiting
First Posted : February 7, 2020
Last Update Posted : February 20, 2020
Sponsor:
Information provided by (Responsible Party):
Anna Cruceta, Fundacion Clinic per a la Recerca Biomédica

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Head Cancer Neck Cancer Melanoma Breast Cancer Drug: Lymphoseek Drug: Nanocoll Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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.
Estimated Study Start Date : March 2020
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : August 2021


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Time frame to ascertain the sentinel nodes [ Time Frame: 1 week ]
  2. Concordance among early and delayed images obtained withLymphoseek® or with albumianocolloid and the SPECT/CT images. [ Time Frame: 1 week ]
  3. Number of sentinel nodes and secondary nodes depicted [ Time Frame: 1 week ]
  4. Tracer retention in injection site [ Time Frame: 1 week ]
  5. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04261179


Locations
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Spain
Hospital Clínico y provincial de Barcelona
Barcelona, Spain, 08036
Contact: Anna Cruceta Arboles, MD       acruceta@clinic.ub.es   
Sponsors and Collaborators
Anna Cruceta
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Responsible Party: Anna Cruceta, Project Manager, Fundacion Clinic per a la Recerca Biomédica
ClinicalTrials.gov Identifier: NCT04261179    
Other Study ID Numbers: 2019-003825-56
First Posted: February 7, 2020    Key Record Dates
Last Update Posted: February 20, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Melanoma
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas