What side effects are associated with this type of intervention?

Common treatments for neuroblastoma, including chemotherapy, radiation therapy, and targeted therapies, can have a range of side effects. Chemotherapy may cause nausea, vomiting, hair loss, and increased infection risk. Radiation therapy can lead to skin irritation, fatigue, and long-term effects like growth delays and secondary cancers. Targeted therapies might cause diarrhea, liver issues, and fatigue. Imaging agents like 18F-mFBG are generally well-tolerated but can occasionally cause mild reactions such as nausea or allergic responses.

What prior FDA approvals exist?

The FDA has approved several treatments for neuroblastoma, including imaging agents and therapeutic drugs. One notable imaging agent is 123I-MIBG (metaiodobenzylguanidine), which is used for both diagnostic imaging and targeted radiotherapy in neuroblastoma. This agent works similarly to 18F-mFBG by targeting neuroblastoma cells, allowing for precise imaging and treatment. Additionally, therapeutic agents like dinutuximab, a monoclonal antibody, have been approved for high-risk neuroblastoma, often used in combination with other treatments such as chemotherapy and immunotherapy.

What other types of research exist?

Promising alternatives to 18F-mFBG for imaging neuroblastoma include 68Ga-DOTATATE PET/CT, which targets somatostatin receptors commonly expressed in neuroblastoma, and 177Lu-DOTATATE, which is used for both imaging and treatment due to its therapeutic properties. These alternatives have shown significant efficacy in detecting and managing neuroendocrine tumors, including neuroblastoma.

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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 below

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I've had or will have a special scan for my neuroblastoma within the last 30 days, with no treatment in between.

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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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and scan interpretation up to one month after intervention. for reporting.

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

0 / 4Eligibility criteria met

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.