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

Phase 4

• Conditions: Head Cancer; Melanoma; Breast Cancer; Neck Cancer
• Interventions: Drug: Lymphoseek; Drug: Nanocoll

• Registration Number: NCT04261179
• Lead Sponsor: Anna Cruceta

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 available

Study Timeline

• Status Verified: 2020-02
• Study First Submitted: 2020-02-05
• Study First Submitted QC: 2020-02-06
• Study First Posted: 2020-02-07
• Last Update Submitted: 2020-02-18
• Last Update Posted: 2020-02-20
• Study Start: 2020-03
• Primary Completion: 2021-02
• Study Completion: 2021-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• 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

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
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lymphoseek + Nanocoll	Lymphoseek	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
Lymphoseek + Nanocoll	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

Primary Outcome Measures

Name	Time	Method
Nodal Concordance: proportion of lymph nodes identified by 99mTc-tilmanocept vs nanocolloidal human serum albumin by lymphoscintigraphies	for at least 48 consecutive hours	number and diameter in millimeters of nodes affected identified by 99mTc-tilmanocept vs nanocolloidal

Secondary Outcome Measures

Name	Time	Method
Time frame to ascertain the sentinel nodes	1 week
Concordance among early and delayed images obtained withLymphoseek® or with albumianocolloid and the SPECT/CT images.	1 week
Number of sentinel nodes and secondary nodes depicted	1 week
Tracer retention in injection site	1 week
Safety and tolerability of 99mTctilmanocept (Lymphoseek®)	1 week	Number of participants with treatment-related adverse events as assessed by Lymphoseek® or with albuminanocolloid

Trial Locations

Locations (1)

Hospital Clínico y provincial de Barcelona; 🇪🇸 Barcelona, Spain