Head Cancer, Neck Cancer, Melanoma, Breast Cancer
Conditions
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
Interventions
DRUGLymphoseek
50 μg microgram(s), timepoint: 30-60 minutes
DRUGNanocoll
500 μg microgram(s), timepoint: 30-60 minutes
Sponsors
Anna Cruceta
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Spain
Outcome results
None listed