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

Anna Cruceta

Status and phase: Unknown; Phase 4

Conditions: Breast Cancer; Melanoma; Head Cancer; Neck Cancer

Treatments: Drug: Nanocoll; Drug: Lymphoseek

Study type: Interventional

Funder types: Other

Identifiers

NCT04261179

2019-003825-56

Details and patient eligibility

About

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

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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).

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Lymphoseek + Nanocoll

Other group

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

Treatment:

Drug: Lymphoseek

Drug: Nanocoll