18F-MFBG Imaging for Neuroblastoma

Recruiting at 7 trial locations

Overseen By A F Jacobson, MD, PhD

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Illumina Radiopharmaceuticals, LLC

Must not be taking: NET-interfering medications

Disqualifiers: Pregnancy, Breastfeeding, Allergies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

43 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

You may need to stop taking certain medications that interfere with the imaging agent used in the study. These medications should be withheld 24 hours before the study procedures.

What data supports the effectiveness of the treatment 18F-MFBG for neuroblastoma?

Research suggests that 18F-MFBG PET/CT imaging is effective in detecting and locating neuroblastoma tumors, potentially outperforming the commonly used 123I-MIBG SPECT/CT scans. ^{1 2 3 4 5}

How does the drug 18F-MFBG differ from other treatments for neuroblastoma?

18F-MFBG is a novel imaging drug used in PET scans that provides fast, high-resolution images of neuroblastoma tumors by targeting the norepinephrine transporter, unlike the traditional 123I-MIBG SPECT scans. This allows for same-day imaging with better lesion targeting and potentially more accurate diagnosis. ^{1 2 4 6 7}

Eligibility Criteria

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.

Inclusion 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.

Exclusion Criteria

The subject has a history or suspicion of significant allergic reaction or anaphylaxis to any components of the 18F-mFBG imaging agent.

The subject was previously entered into this study.

The subject is pregnant, breast feeding, or menarchal and unwilling to use effective contraception during the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo 18F-mFBG PET imaging to assess presence of neuroblastoma

1 day

1 visit (in-person)

Follow-up

Participants are monitored for adverse events and safety assessments post-imaging

24 hours

1 visit (in-person)

Data Analysis

Blinded evaluation of imaging results by independent radiologists and comparison with expert oncologist assessments

Up to 1 month

Treatment Details

Interventions

• 18F-MFBG

Trial Overview 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.

Participant Groups

Group I: Study Cohort: Subjects with known or presumed neuroblastoma Experimental Treatment 1 Intervention

Drug: 18F-mFBG Positron-emitting radiopharmaceutical 18F-mFBG as an imaging agent for identification of neuroblastoma. Other Names: * meta-fluorobenzylguanidine * IRP101

Who Is Running the Clinical Trial?

Illumina Radiopharmaceuticals, LLC

Lead Sponsor

Trials

2

Recruited

60+

Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC)

Lead Sponsor

Trials

3

Recruited

60+

Memorial Sloan Kettering Cancer Center

Collaborator

Trials

1,998

Recruited

602,000+

New Approaches to Neuroblastoma Therapy Consortium

Collaborator

Trials

19

Recruited

1,700+

Findings from Research

In a study of 55 children with newly diagnosed neuroblastic tumors, higher metabolic activity (measured by SUVmax and SUVmean) was found in MYCN-amplified tumors and higher International Neuroblastoma Risk Group stages, indicating a correlation between tumor activity and aggressiveness.

While higher SUVmax and SUVmean were associated with worse overall survival, they were not independent predictors when considering other factors like MYCN status and treatment risk, suggesting that these PET metrics should be used alongside other prognostic indicators.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prognostic significance of pretreatment 18F-FDG positron emission tomography/computed tomography in pediatric neuroblastoma. Sung, AJ., Weiss, BD., Sharp, SE., et al.[2021]

References

1. Germany pubmed.ncbi.nlm.nih.gov

[18F]mFBG PET-CT for detection and localisation of neuroblastoma: a prospective pilot study. [2023]

2. Germany pubmed.ncbi.nlm.nih.gov

[18F]MFBG PET/CT outperforming [123I]MIBG SPECT/CT in the evaluation of neuroblastoma. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Comparison of iodine-123 metaiodobenzylguanidine (MIBG) scan and [18F]fluorodeoxyglucose positron emission tomography to evaluate response after iodine-131 MIBG therapy for relapsed neuroblastoma. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Diagnostic value of 18F-FDG PET/CT in paediatric neuroblastoma: comparison with 131I-MIBG scintigraphy. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

¹²³I-MIBG scintigraphy/SPECT versus ¹⁸F-FDG PET in paediatric neuroblastoma. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Biodistribution and Dosimetry of 18F-Meta-Fluorobenzylguanidine: A First-in-Human PET/CT Imaging Study of Patients with Neuroendocrine Malignancies. [2023]

7. Germany pubmed.ncbi.nlm.nih.gov

Prognostic significance of pretreatment 18F-FDG positron emission tomography/computed tomography in pediatric neuroblastoma. [2021]