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

Primary Purpose

Head Cancer, Neck Cancer, Melanoma

Status
Unknown status
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Lymphoseek
Nanocoll
Sponsored by
Anna Cruceta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Head Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Hospital Clínico y provincial de Barcelona

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Lymphoseek + Nanocoll

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 5, 2020
Last Updated
February 18, 2020
Sponsor
Anna Cruceta
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1. Study Identification

Unique Protocol Identification Number
NCT04261179
Brief Title
Study Comparing Lymphoseek® vs. Albumin Nanocolloid in Head and Neck, Melanoma and Breast Cancer
Acronym
SENTINELSEEK
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.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 2020 (Anticipated)
Primary Completion Date
February 2021 (Anticipated)
Study Completion Date
August 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Anna Cruceta

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head Cancer, Neck Cancer, Melanoma, Breast Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lymphoseek + Nanocoll
Arm Type
Other
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Lymphoseek
Intervention Description
50 μg microgram(s), timepoint: 30-60 minutes
Intervention Type
Drug
Intervention Name(s)
Nanocoll
Intervention Description
500 μg microgram(s), timepoint: 30-60 minutes
Primary Outcome Measure Information:
Title
Nodal Concordance: proportion of lymph nodes identified by 99mTc-tilmanocept vs nanocolloidal human serum albumin by lymphoscintigraphies
Description
number and diameter in millimeters of nodes affected identified by 99mTc-tilmanocept vs nanocolloidal
Time Frame
for at least 48 consecutive hours
Secondary Outcome Measure Information:
Title
Time frame to ascertain the sentinel nodes
Time Frame
1 week
Title
Concordance among early and delayed images obtained withLymphoseek® or with albumianocolloid and the SPECT/CT images.
Time Frame
1 week
Title
Number of sentinel nodes and secondary nodes depicted
Time Frame
1 week
Title
Tracer retention in injection site
Time Frame
1 week
Title
Safety and tolerability of 99mTctilmanocept (Lymphoseek®)
Description
Number of participants with treatment-related adverse events as assessed by Lymphoseek® or with albuminanocolloid
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Facility Information:
Facility Name
Hospital Clínico y provincial de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Cruceta Arboles, MD
Email
acruceta@clinic.ub.es

12. IPD Sharing Statement

Plan to Share IPD
No

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

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