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

• ClinicalTrials.gov Identifier: NCT04261179
• Recruitment Status: Not yet recruiting
• First Posted: February 7, 2020
• Last Update Posted: February 20, 2020
• Sponsor: Anna Cruceta
• Information provided by (Responsible Party): Anna Cruceta, Fundacion Clinic per a la Recerca Biomédica

Tracking Information

• First Submitted Date: February 5, 2020
• First Posted Date: February 7, 2020
• Last Update Posted Date: February 20, 2020
• Estimated Study Start Date: March 2020
• Estimated Primary Completion Date: February 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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]

Current Secondary Outcome Measures (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 (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: Study Comparing Lymphoseek® vs. Albumin Nanocolloid in Head and Neck, Melanoma and Breast Cancer
• 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.
• 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic

Condition

• Head Cancer
• Neck Cancer
• Melanoma
• Breast Cancer

Intervention

• Drug: Lymphoseek
  50 μg microgram(s), timepoint: 30-60 minutes
• Drug: Nanocoll
  500 μg microgram(s), timepoint: 30-60 minutes

Study Arms

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

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: February 6, 2020): 30
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: August 2021
• Estimated Primary Completion Date: February 2021 (Final data collection date for primary outcome measure)

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).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Listed Location Countries: Spain

Administrative Information

• NCT Number: NCT04261179
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Responsible Party: Anna Cruceta, Fundacion Clinic per a la Recerca Biomédica
• Study Sponsor: Anna Cruceta
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Fundacion Clinic per a la Recerca Biomédica
• Verification Date: February 2020