SENTINELSEEK: Study Comparing Lymphoseek® vs. Albumin Nanocolloid in Head and Neck, Melanoma and Breast Cancer

• Sponsor: Anna Cruceta (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04261179
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 17
• Patients Per Site Per Month: 1.8

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Head Cancer; Neck Cancer; Melanoma; Breast Cancer	Drug: Lymphoseek; Drug: Nanocoll	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official 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.
• Anticipated Study Start Date: Mar 1, 2020
• Anticipated Primary Completion Date: Feb 1, 2021
• Anticipated Study Completion Date: Aug 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: 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	Drug: Lymphoseek; 50 μg microgram(s), timepoint: 30-60 minutes; Drug: Nanocoll; 500 μg microgram(s), timepoint: 30-60 minutes

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. Time frame to ascertain the sentinel nodes [1 week]

2. Concordance among early and delayed images obtained withLymphoseek® or with albumianocolloid and the SPECT/CT images. [1 week]

3. Number of sentinel nodes and secondary nodes depicted [1 week]

4. Tracer retention in injection site [1 week]

5. Safety and tolerability of 99mTctilmanocept (Lymphoseek®) [1 week]

   Number of participants with treatment-related adverse events as assessed by Lymphoseek® or with albuminanocolloid

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Clínico y provincial de Barcelona	Barcelona		Spain	08036

Sponsors and Collaborators

• Anna Cruceta

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Anna Cruceta, Project Manager, Fundacion Clinic per a la Recerca Biomédica
• ClinicalTrials.gov Identifier: NCT04261179
• Other Study ID Numbers: 2019-003825-56
• First Posted: Feb 7, 2020
• Last Update Posted: Feb 20, 2020
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Breast Neoplasms; Melanoma; Head and Neck Neoplasms

Study Results

No Results Posted as of Feb 20, 2020