Breast Cancer Clinical Trial
— SENTINELSEEKOfficial 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.
Verified date | February 2020 |
Source | Fundacion Clinic per a la Recerca Biomédica |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
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). |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Clínico y provincial de Barcelona | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Anna Cruceta |
Spain,
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 |
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