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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.
Must not have
The subject uses medications that are known to interfere with uptake of NET-dependent agents and these medications cannot be safely withheld 24 hours before study procedures.
The subject is unable to lie flat or remain still for approximately 30 minutes to allow performance of a PET scan.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up scan interpretation up to one month after intervention.
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial is testing a new imaging agent called 18F-mFBG to see if it can help doctors find neuroblastoma, a type of cancer. It targets patients who either have been diagnosed with neuroblastoma or show signs that suggest they might have it. The agent works by lighting up areas in the body where cancer might be, making it easier to confirm or rule out the disease. 18F-mFBG is a promising new tool for specifically imaging neuroblastomas.
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I take medications that cannot be stopped for 24 hours before the study procedures.
Select...
I cannot stay still or lie flat for 30 minutes for a scan.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
PET Scan Identification of Neuroblastoma
Secondary study objectives
Positron-Emission Tomography
Number of subjects with adverse events graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.
Awards & Highlights
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.
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
18F-MFBG
2021
Completed Phase 3
~50
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Neuroblastoma include chemotherapy, radiation therapy, surgery, and immunotherapy. Chemotherapy uses drugs like cisplatin and etoposide to kill rapidly dividing cancer cells by damaging their DNA.
Radiation therapy uses high-energy particles to destroy cancer cells and shrink tumors. Surgery aims to remove as much of the tumor as possible.
Immunotherapy, such as anti-GD2 antibodies, targets specific proteins on cancer cells to help the immune system recognize and destroy them. These treatments are crucial for Neuroblastoma patients as they address the aggressive nature of the disease, aiming to reduce tumor size, eliminate cancer cells, and improve survival rates.
The 18F-mFBG trial, while focused on imaging, helps in accurately diagnosing and staging the disease, which is essential for tailoring effective treatment plans.
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterOTHER
1,975 Previous Clinical Trials
598,817 Total Patients Enrolled
50 Trials studying Neuroblastoma
5,789 Patients Enrolled for Neuroblastoma
Illumina Radiopharmaceuticals, LLCLead Sponsor
1 Previous Clinical Trials
20 Total Patients Enrolled
New Approaches to Neuroblastoma Therapy ConsortiumOTHER
18 Previous Clinical Trials
1,653 Total Patients Enrolled
18 Trials studying Neuroblastoma
1,653 Patients Enrolled for Neuroblastoma
Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC)Lead Sponsor
2 Previous Clinical Trials
49 Total Patients Enrolled
1 Trials studying Neuroblastoma
29 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.