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

Breast Cancer Clinical Trial

— 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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04261179
• Other study ID #: 2019-003825-56
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: March 2020
• Est. completion date: August 2021

Study information

• Verified date: February 2020
• Source: Fundacion Clinic per a la Recerca Biomédica
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: August 2021
• Est. primary completion date: February 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Head and Neck Neoplasms
• Head Cancer
• Melanoma
• Neck Cancer

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Clínico y provincial de Barcelona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Anna Cruceta

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	for at least 48 consecutive hours
Secondary	Time frame to ascertain the sentinel nodes		1 week
Secondary	Concordance among early and delayed images obtained withLymphoseek® or with albumianocolloid and the SPECT/CT images.		1 week
Secondary	Number of sentinel nodes and secondary nodes depicted		1 week
Secondary	Tracer retention in injection site		1 week
Secondary	Safety and tolerability of 99mTctilmanocept (Lymphoseek®)	Number of participants with treatment-related adverse events as assessed by Lymphoseek® or with albuminanocolloid	1 week