18F-MFBG Imaging for Neuroblastoma

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new imaging agent called 18F-mFBG to confirm or rule out neuroblastoma, a cancer that usually affects young children. The researchers aim to determine if 18F-mFBG can provide clearer images of neuroblastoma compared to existing methods. Individuals diagnosed with neuroblastoma or strongly suspected of having it might be suitable candidates, especially if they have already undergone or will soon undergo certain imaging tests. As a Phase 3 trial, this represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking diagnostic advancement.

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 prior data suggests that 18F-mFBG is safe as an imaging agent for neuroblastoma?

Research has shown that 18F-MFBG, a special imaging drug for neuroblastoma, is generally safe for patients. In one study with neuroblastoma patients, researchers found no major safety problems with 18F-MFBG. Early results also indicate that this imaging method is well-tolerated, spreads effectively in the body, and targets cancerous areas efficiently. Although safety information is limited, current evidence suggests that 18F-MFBG is a safe choice for imaging in neuroblastoma cases. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about 18F-MFBG for imaging neuroblastoma because it offers a novel approach to detecting this type of cancer. Unlike traditional imaging agents, 18F-MFBG uses a positron-emitting radiopharmaceutical, which could provide more detailed images of the cancer's location and extent. This enhanced imaging capability can help doctors better understand the disease and potentially tailor treatments more effectively, ultimately improving patient outcomes.

What evidence suggests that 18F-MFBG is effective for imaging neuroblastoma?

Studies have shown that 18F-mFBG PET/CT effectively detects neuroblastoma, a type of cancer. It often surpasses other imaging methods like SSTR PET, which target different tumors. Research indicates that 18F-mFBG can accurately confirm the presence or absence of neuroblastoma. This trial will use 18F-mFBG as an imaging agent to stage the disease, determining how much cancer is in the body and its location. Overall, 18F-mFBG PET/CT offers a reliable method for detecting neuroblastoma. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40717185/

[18F]MFBG PET/CT is an effective and preferable imaging ...

[18F]MFBG PET/CT is an effective and preferable imaging modality for neuroblastoma in a prospective comparison with SSTR PET · Abstract.

2.

link.springer.com

link.springer.com/article/10.1007/s00259-025-07449-y

[18F]MFBG PET/CT is an effective and preferable imaging ...

SSTR PET imaging, widely used in neuroendocrine tumors, has shown potential in staging neuroblastoma and identifying candidates for peptide ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04724369

Open-Label Study of 18F-mFBG for Imaging Neuroblastoma

It identifies the role of the intervention that participants receive. Types of arms include experimental arm, active comparator arm, placebo comparator arm, ...

4.

jnm.snmjournals.org

jnm.snmjournals.org/content/66/supplement_1/252135

Evaluating the Efficacy of 18F-MFBG PET/CT in Differentiating ...

Conclusions: 18F-MFBG PET/CT is an effective imaging modality ... Comparison of 18F-MFBG PET/CT and MRI in the evaluation of Neuroblastoma.

5.

nature.com

nature.com/articles/s41598-020-77788-3

18F-meta-fluorobenzylguanidine (18F-mFBG) to monitor ...

[18F]MFBG PET/CT is an effective and preferable imaging modality for neuroblastoma in a prospective comparison with SSTR PET. Peipei Wang; Sun ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39641193/

Safety observations in neuroblastoma patients undergoing ...

In this investigation of the potential clinical utility of m FBG PET imaging, no significant adverse safety signals were noted.

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06852807

18F-mFBG PET Imaging in the Evaluation of Neuroblastoma

Preliminary data show that 18F-MFBG imaging is safe and has favorable biodistribution and kinetics with good targeting of lesions. Patients can undergo PET ...

8.

researchgate.net

researchgate.net/publication/386504819_Safety_observations_in_neuroblastoma_patients_undergoing_18F-mFBG_PET

Safety observations in neuroblastoma patients undergoing ...

Objective Limited safety data have been published on fluorine-18 ( ¹⁸ F) meta-fluorobenzylguanidine ( m FBG), a new PET radiopharmaceutical for imaging ...

9.

jnm.snmjournals.org

jnm.snmjournals.org/content/early/2025/09/02/jnumed.125.269833.abstract

Lesion Analysis of 18F-Metafluorobenzylguanidine PET ...

We now report a comprehensive analysis of lesion detection with 18F-MFBG imaging in patients with neuroblastoma compared with 123I-MIBG imaging.

10.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.2023.41.16_suppl.10046

18F-MFBG PET imaging in patients with neuroblastoma

MFBG scan detected disease in all patients with MIBG positive disease. MFBG detected similar or more lesions compared to MIBG in patients with neuroblastoma.