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

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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

Tracking Information
First Submitted Date  ICMJE February 5, 2020
First Posted Date  ICMJE February 7, 2020
Last Update Posted Date February 20, 2020
Estimated Study Start Date  ICMJE March 2020
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 18, 2020)
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
Original Primary Outcome Measures  ICMJE
 (submitted: February 6, 2020)
Nodal Concordance [ Time Frame: for at least 48 consecutive hours ]
Nodal Concordance defined as the proportion of lymph nodes the proportion of lymph nodes identified by 99mTc-tilmanocept (Lymphoseek®) compared to the number of lymph nodes identified by nanocolloidal human serum albumin (Nanococoll® ) by performing two separate preoperative lymphoscintigraphies [Washout period: 2 Days) (Nanocolloid®) by performing two separate pre-operative lymphoscintigraphies [Washout period: 2 Day]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 17, 2020)
  • Time frame to ascertain the sentinel nodes [ Time Frame: 1 week ]
  • Concordance among early and delayed images obtained withLymphoseek® or with albumianocolloid and the SPECT/CT images. [ Time Frame: 1 week ]
  • Number of sentinel nodes and secondary nodes depicted [ Time Frame: 1 week ]
  • Tracer retention in injection site [ Time Frame: 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
Original Secondary Outcome Measures  ICMJE
 (submitted: February 6, 2020)
  • Time frame to ascertain the sentinel nodes [ Time Frame: 1 week ]
  • Concordance among early and delayed images obtained withLymphoseek® [ Time Frame: 1 week ]
    and Concordance among early and delayed images obtained with Lymphoseek® or with albumianocolloid and the SPECT/CT images.
  • Number of sentinel nodes and secondary nodes depicted [ Time Frame: 1 week ]
  • Tracer retention in injection site [ Time Frame: 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Comparing Lymphoseek® vs. Albumin Nanocolloid in Head and Neck, Melanoma and Breast Cancer
Official Title  ICMJE 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.
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Head Cancer
  • Neck Cancer
  • Melanoma
  • Breast Cancer
Intervention  ICMJE
  • Drug: Lymphoseek
    50 μg microgram(s), timepoint: 30-60 minutes
  • Drug: Nanocoll
    500 μg microgram(s), timepoint: 30-60 minutes
Study Arms  ICMJE 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
Interventions:
  • Drug: Lymphoseek
  • Drug: Nanocoll
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: February 6, 2020)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2021
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04261179
Other Study ID Numbers  ICMJE 2019-003825-56
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Anna Cruceta, Fundacion Clinic per a la Recerca Biomédica
Study Sponsor  ICMJE Anna Cruceta
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Fundacion Clinic per a la Recerca Biomédica
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP