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.
Conditions
Interventions
Trade Name: Lymphoseek
Pharmaceutical Form: Radiopharmaceutical precursor
INN or Proposed INN: TILMANOCEPT
CAS Number: 1262984-82-6
Othe
Sponsors
Fundació Clínic per a la Recerca Biomèdica
Eligibility
Sex/Gender
All
Inclusion 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 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
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Nodal Concordance defined as the proportion of lymph nodes identified by 99mTc-tilmanocept (Lymphoseek®) compared to the number of lymph nodes identified by nanocolloidal human serum albumin (Nanocolloid®) by performing two separate pre-operative lymphoscintigraphies [Washout period: 2 Day]; Secondary Objective: ? Time frame to ascertain the sentinel nodes ? Concordance among early and delayed images obtained with Lymphoseek® ? Number of sentinel nodes and secondary nodes depicted ? Tracer retention in injection site ? Safety and tolerability of 99mTctilmanocept (Lymphoseek®) ;Primary end point(s): Assessment of the concordance of albumin nanocolloid and Lymphoseek® in lymphatic drainage including the detection of both, primary and secondary lymph nodes, by means of a limphoscintigraphy with standardized dynamic study which includes early and delayed images and an SPECT/CT.;Timepoint(s) of evaluation of this end point: 30-60 minutes | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 30-60 minutes; Secondary end point(s): Secondary Efficacy endpoints: ? Per subject concordance of the lymphatic node stations detected with both radiotracers and the SPECT/CT images. ? Per subject concordance of the timeframe to ascertain sentinel nodes. Time to localization of the sentinel node would be assessed by limphoscintigraphy due to the impossibility to asses both times intraoperatively. ? Per subject concordance in the number of sentinel nodes detected and secondary nodes depicted among Lymphoseek® and albumianocolloid and the SPECT/CT images. ? Concordance among early and delayed images obtained with Lymphoseek® and the SPECT/CT Other secondary endpoints ? Adverse events [Timeframe 7 days]. | — |
Countries
Spain
Contacts
Public ContactAnna Cruceta
CTU CLINIC
Outcome results
None listed