A Study of Lymphoseek® as a Lymphoid Tissue Targeting Agent in Pediatric Patients With Melanoma, … (NCT02509598) | Clinical Trial Compass
CompletedPhase 2
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
United States24 participantsStarted 2015-08
Plain-language 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.
Who can participate
Age range
17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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 radiopharm…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Average Number of Lymph Nodes Identified Intraoperatively Per Subject