Study Comparing Lymphoseek® vs. Albumin Nanocolloid in Head and Neck, Melanoma and Breast Cancer
NCT ID: NCT04261179
Last Updated: 2020-02-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
30 participants
INTERVENTIONAL
2020-03-31
2021-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Lymphoseek + 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
Lymphoseek
50 μg microgram(s), timepoint: 30-60 minutes
Nanocoll
500 μg microgram(s), timepoint: 30-60 minutes
Interventions
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Lymphoseek
50 μg microgram(s), timepoint: 30-60 minutes
Nanocoll
500 μg microgram(s), timepoint: 30-60 minutes
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
ALL
No
Sponsors
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Anna Cruceta
OTHER
Responsible Party
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Anna Cruceta
Project Manager
Locations
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Hospital Clínico y provincial de Barcelona
Barcelona, , Spain
Countries
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Facility Contacts
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Other Identifiers
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2019-003825-56
Identifier Type: -
Identifier Source: org_study_id
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