Clinical trial · Interventional
Study Comparing Lymphoseek® vs. Albumin Nanocolloid in Head and Neck, Melanoma and Breast Cancer
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.
NCT04261179CI-TRIAL-00043544SENTINELSEEKunknownPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Head Cancer | — | UNRESOLVED | — |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| Neck Cancer | Malignant Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lymphoseek | Drug | — | UNRESOLVED |
| Nanocoll | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Lymphoseek + Nanocoll
- description
- 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
- interventionNames
- Drug: Lymphoseek
- Drug: Nanocoll
Primary outcomes (1)
- measure
- Nodal Concordance: proportion of lymph nodes identified by 99mTc-tilmanocept vs nanocolloidal human serum albumin by lymphoscintigraphies
- timeFrame
- for at least 48 consecutive hours
- description
- number and diameter in millimeters of nodes affected identified by 99mTc-tilmanocept vs nanocolloidal
Secondary outcomes (5)
- measure
- Time frame to ascertain the sentinel nodes
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available
No reference posted for this study.