A Study of Lymphoseek® as a Lymphoid Tissue Targeting Agent in Pediatric Patients With Melanoma, Rhabdomyosarcoma, or Other Solid Tumors Who Are Undergoing Lymph Node Mapping
A Prospective, Open-Label, Multicenter Study of Lymphoseek® as a Lymphoid Tissue Targeting Agent in Pediatric Patients With Melanoma, Rhabdomyosarcoma, or Other Solid Tumors Who Are Undergoing Lymph Node Mapping
1 other identifier
interventional
24
1 country
6
Brief Summary
Open label, non-randomized, multi-center, within-subject comparative study to evaluate the tolerability and the diagnostic utility of Lymphoseek with optional comparison to VBD in pediatric subjects with melanoma, rhabdomyosarcoma, or other solid tumor. Subject age will range from neonatal through 17 years.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Aug 2015
Typical duration for phase_2
6 active sites
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
July 24, 2015
CompletedFirst Posted
Study publicly available on registry
July 28, 2015
CompletedStudy Start
First participant enrolled
August 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 6, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 6, 2019
CompletedResults Posted
Study results publicly available
June 28, 2024
CompletedJune 28, 2024
June 1, 2024
3.6 years
July 24, 2015
May 8, 2024
June 26, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Average Number of Lymph Nodes Identified Intraoperatively Per Subject
1 Day
Subject Localization Rates
The proportion of subjects with Lymphoseek-identified lymph nodes
1 Day
Secondary Outcomes (10)
Proportion of Subjects Who Underwent Preoperative SPECT or SPECT/CT
1 Day
Proportion of Subjects With a Lymph Node Identified Preoperatively Using SPECT or SPECT/CT
1 day
Average Number of Lymph Nodes Identified Preoperatively Using SPECT or SPECT/CT Per Subject
1 Day
Agreement of the Number of Nodes Identified by Preoperative SPECT or SPECT/CT to Intraoperative Localization
1 Day
Upstaging
1 Day
- +5 more secondary outcomes
Study Arms (1)
Tc99m tilmanocept and Vital Blue Dye (optional)
EXPERIMENTAL0.5 mCi, 50 ug of Tc99m tilmanocept single administration. Optionally, 1-3 mL of vital blue dye, single administration (per institution's standard of care).
Interventions
A single dose of 0.5 mCi and 50 ug of Tc99m tilmanocept administered intradermally, peritumorally approximately 15 minutes to 8 hours before surgery
A single dose 1-3 mL of vital blue dye (1%) administered intradermally at the start of or during surgery (optional, per institution's standard of care).
Intraoperative lymph node mapping will occur 15 minutes to 8 hours after Tc99m tilmanocept injection
Eligibility Criteria
You may qualify if:
- The subject's parent(s)/legal guardian(s) understand(s) and voluntarily signed an informed consent document prior to any study-related assessments/procedures being conducted. Where locally applicable, the subject also understands and voluntarily provides his/her assent prior to any study-related assessments/procedures being conducted
- Subject has been diagnosed with melanoma, rhabdomyosarcoma, or other tumor where tumor resection or biopsy is planned and lymph node mapping is appropriate
- The subject is clinically node negative (cN0) at the time of screening
- Age \< 18 years
- Male subjects of childbearing potential must be willing to use a condom during sexual intercourse and shall not father a child during the course of the study or will practice complete abstinence while on study
- Female subjects of childbearing potential must agree to the use of two physician-approved contraceptive methods simultaneously or practice complete abstinence while on study
You may not qualify if:
- The subject has had preoperative radiation therapy
- Has had previous surgery or radiation to node basins that would be involved in the intraoperative lymph node mapping (ILM) procedure
- Has a known allergy to dextran or VBD (if intended to be used)
- Has a history of alcohol abuse or alcohol dependency in the 3 years before study entry, or is an alcoholic or drug addict, as determined by the investigator
- Before the administration of Lymphoseek, has received any radiopharmaceutical within 7 radioactive half-lives of that radiopharmaceutical
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Nemours Children's Specialty Care
Jacksonville, Florida, 32207, United States
Nemours Children's Hopsital
Orlando, Florida, 32827, United States
Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director, Regulatory & Medical Affairs
- Organization
- Cardinal Health 414, LLC
Study Officials
- STUDY DIRECTOR
Michael Blue, MD
Cardinal Health 414, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 24, 2015
First Posted
July 28, 2015
Study Start
August 1, 2015
Primary Completion
March 6, 2019
Study Completion
March 6, 2019
Last Updated
June 28, 2024
Results First Posted
June 28, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will not share