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.

Phase 1

• Conditions: The hypothesis is that 99mTc-tilmanocept (Lymphoseek®) can be used safely and will be comparable to nanocolloidal human serum nanocolloidal albumin in Head and Neck, Melanoma and Breast Cancer sentinel lymph node detection and mapping.; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2019-003825-56-ES
• Lead Sponsor: Fundació Clínic per a la Recerca Biomèdica

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-10
• Last Update Posted: 11 March 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 30

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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified