NCT04261179

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 7, 2020

Completed
23 days until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

February 20, 2020

Status Verified

February 1, 2020

Enrollment Period

11 months

First QC Date

February 5, 2020

Last Update Submit

February 18, 2020

Conditions

Head CancerNeck CancerMelanomaBreast Cancer

Outcome Measures

Primary Outcomes (1)

  • Nodal Concordance: proportion of lymph nodes identified by 99mTc-tilmanocept vs nanocolloidal human serum albumin by lymphoscintigraphies

    number and diameter in millimeters of nodes affected identified by 99mTc-tilmanocept vs nanocolloidal

    for at least 48 consecutive hours

Secondary Outcomes (5)

  • 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

Study Arms (1)

Lymphoseek + Nanocoll

OTHER

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: LymphoseekDrug: Nanocoll

Interventions

LymphoseekDRUG

50 μg microgram(s), timepoint: 30-60 minutes

Lymphoseek + Nanocoll
NanocollDRUG

500 μg microgram(s), timepoint: 30-60 minutes

Lymphoseek + Nanocoll

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clínico y provincial de Barcelona

Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsMelanomaBreast Neoplasms

Interventions

technetium-diethylenetriaminepentaacetic acid-mannosyl-dextrantechnetium Tc 99m nanocolloid

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsSkin DiseasesSkin and Connective Tissue DiseasesBreast Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Project Manager

Study Record Dates

First Submitted

February 5, 2020

First Posted

February 7, 2020

Study Start

March 1, 2020

Primary Completion

February 1, 2021

Study Completion

August 1, 2021

Last Updated

February 20, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)