Overview

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

Status:
Not yet recruiting
Trial end date:
2021-08-01
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Anna Cruceta
Treatments:
Dextrans
Technetium Tc 99m Pentetate
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).