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18F-MFBG Imaging for Neuroblastoma
Phase 3
Waitlist Available
Research Sponsored by Illumina Radiopharmaceuticals, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
The subject has undergone or is scheduled to undergo evaluation of neuroblastoma disease status, including at least one functional imaging study (123I-mIBG or 18F-FDG), within 30 days prior to the date of 18F-mFBG imaging, with no interval therapy between such evaluation and investigational drug administration.
Ability of subject or subject's legal guardian to understand and sign a written informed consent document, including, for subjects age 7-17, an assent form.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up scan interpretation up to one month after intervention.
Awards & highlights
Study Summary
This trial is testing a new imaging agent to see if it can help confirm or rule out the presence of neuroblastoma.
Who is the study for?
This trial is for individuals with a confirmed or presumed diagnosis of neuroblastoma, who have had recent imaging studies to assess their disease status. Participants must be able to give informed consent and, if they are minors, assent. Pregnant or breastfeeding individuals, those with significant allergies to the study drug's components, or those unable to remain still for PET scans are excluded.Check my eligibility
What is being tested?
The study is testing 18F-mFBG as an imaging agent in patients with neuroblastoma. This Phase 3 trial aims to determine how well this radiopharmaceutical helps in confirming or ruling out the presence of neuroblastoma when used in PET scans.See study design
What are the potential side effects?
While specific side effects aren't listed here, potential risks may include allergic reactions similar to other contrast agents used in imaging procedures. Patients should discuss individual risk factors and concerns about side effects with the research team.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I've had or will have a special scan for my neuroblastoma within the last 30 days, with no treatment in between.
Select...
I, or my legal guardian, can understand and sign the consent form.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ scan interpretation up to one month after intervention.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~scan interpretation up to one month after intervention.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
PET Scan Identification of Neuroblastoma
Secondary outcome measures
Positron-Emission Tomography
Number of subjects with adverse events graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Study Cohort: Subjects with known or presumed neuroblastomaExperimental Treatment1 Intervention
Drug: 18F-mFBG Positron-emitting radiopharmaceutical 18F-mFBG as an imaging agent for identification of neuroblastoma.
Other Names:
meta-fluorobenzylguanidine
IRP101
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterOTHER
1,933 Previous Clinical Trials
585,579 Total Patients Enrolled
49 Trials studying Neuroblastoma
5,748 Patients Enrolled for Neuroblastoma
Illumina Radiopharmaceuticals, LLCLead Sponsor
1 Previous Clinical Trials
20 Total Patients Enrolled
New Approaches to Neuroblastoma Therapy ConsortiumOTHER
16 Previous Clinical Trials
1,591 Total Patients Enrolled
16 Trials studying Neuroblastoma
1,591 Patients Enrolled for Neuroblastoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I, or my legal guardian, can understand and sign the consent form.I have been diagnosed with neuroblastoma, either through a biopsy or based on my symptoms and tests.I've had or will have a special scan for my neuroblastoma within the last 30 days, with no treatment in between.I take medications that cannot be stopped for 24 hours before the study procedures.I cannot stay still or lie flat for 30 minutes for a scan.
Research Study Groups:
This trial has the following groups:- Group 1: Study Cohort: Subjects with known or presumed neuroblastoma
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is 18F-MFBG accepted by the US Food and Drug Administration?
"There is pre-existing clinical evidence affirming 18F-MFBG's safety, so it was given a score of 3."
Answered by AI
Are there different research centers participating in this experiment across the country?
"This clinical trial has 8 sites, which are located in Los Angeles (Children's Hospital Los Angeles), Philadelphia (The Children's Hospital of Philadelphia), New york (Memorial Sloan Kettering Cancer Center)."
Answered by AI
How many people are being given lenalidomide in this study?
"A total of 50 individuals are needed for this research project. These people must meet the pre-specified inclusion criteria and can hail from various locations, such as Children's Hospital Los Angeles or The Children's Hospital of Philadelphia."
Answered by AI
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