18F-mFBG Imaging for Neural Crest Tumors

No longer recruiting at 1 trial location

Overseen By Arnold F Jacobson, MD, PhD

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC)

Must not be taking: Antidepressants, Sympathomimetics

Disqualifiers: Pregnancy, Allergies, Prior enrollment, others

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

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 method called 18F-mFBG PET, an imaging agent, to evaluate its effectiveness in detecting certain tumors, such as neuroblastoma, a cancer affecting nerve tissues. The researchers aim to compare this method with current imaging techniques to determine if it provides better images or detects tumors more effectively. The study also examines how imaging results change over time and whether lower doses of the imaging agent are effective. Individuals with a confirmed diagnosis of neuroblastoma who are scheduled for surgery or a biopsy within the next three weeks may be suitable for this trial. As a Phase 2 trial, this research measures the imaging method's effectiveness in an initial, smaller group, offering a chance to contribute to advancements in cancer detection.

Will I have to stop taking my current medications?

You may need to stop taking certain medications that interfere with the study, like some antidepressants and sympathomimetics (drugs that mimic the effects of adrenaline), at least 24 hours before the study procedures. If these medications cannot be safely stopped, you may not be eligible to participate.

What prior data suggests that this imaging agent is safe?

Research has shown that 18F-mFBG, a new imaging tool for PET scans, has been tested in patients with neuroblastoma, a type of cancer. So far, researchers have found no major safety issues. Although extensive safety data is lacking, studies indicate that patients did not experience significant side effects during the imaging process. This suggests that 18F-mFBG is generally safe to use. However, since the research remains in the early stages, monitoring for any potential risks is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about 18F-mFBG imaging for neural crest tumors because it offers a new way to visualize these tumors using a PET scan. Unlike standard imaging methods like MIBG scans, which rely on iodine-123, 18F-mFBG uses a fluorine-18 radiotracer. This potentially allows for clearer images and more precise detection of tumor activity. Additionally, the use of fluorine-18 may provide faster results and better resolution, helping doctors make quicker and more informed decisions about treatment strategies.

What evidence suggests that 18F-mFBG imaging is effective for detecting neural crest tumors?

Research has shown that 18F-mFBG PET imaging, which participants in this trial will undergo, effectively detects neuroblastoma, a tumor developing from nerve tissue. Studies have found that it identifies more neuroblastoma spots in the body compared to other imaging methods like 18F-FDG PET/CT. This effectiveness arises because 18F-mFBG targets and highlights areas with high levels of norepinephrine transporter, often present in these tumors. Additionally, 18F-mFBG provides clearer images quickly, benefiting both doctors and patients. Overall, it seems to be a promising tool for detecting and managing neuroblastoma. ^{3 4 6 7 8}

Who Is on the Research Team?

Alice Lee, MD

Principal Investigator

Montefiore Medical Center/Albert Einstein College of Medicine

Are You a Good Fit for This Trial?

This trial is for individuals with neuroblastoma, paraganglioma, or pheochromocytoma. It's designed to see how well a new imaging agent called 18F-mFBG shows these tumors and organs affected by the sympathetic nervous system on PET scans.

Inclusion Criteria

I am scheduled for a procedure to examine a tumor or organ connected to my nervous system soon.

I have a confirmed diagnosis of neuroblastoma and will undergo a procedure soon.

All subjects: The subject is able and willing to comply with study procedures and a signed and dated informed consent (supplemented by signed and dated assent from subjects age 7-17) is obtained from the subject and/or at least 1 parent/guardian.

Exclusion Criteria

Subjects will not be eligible for participation in the study if they meet ANY of the following criteria: Previously enrolled in this study. Unable to lie flat or remain still for approximately 30 minutes to allow performance of a PET scan. The subject has a history or suspicion of significant allergic reaction or anaphylaxis to any components of the 18F-mFBG imaging agent. The subject is pregnant, breast feeding, or menarchal and unwilling to use effective contraception during the study. Uses medications that are known to interfere with uptake of NET-dependent agents (e.g., certain antidepressants and sympathomimetics) and these medications cannot be safely withheld 24 hours before study procedures.

I have a confirmed diagnosis of neuroblastoma or a related condition that requires a biopsy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging and Tissue Sampling

Participants undergo 18F-mFBG PET imaging and tissue sampling for NET expression analysis

3 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging and tissue sampling

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• 18F-mFBG

Trial Overview The study tests the effectiveness of an imaging agent, 18F-mFBG, in detecting neural crest tumors using PET scans. It compares this agent's performance to other similar agents and checks image quality at various doses over time.

How Is the Trial Designed?

Group I: Neural crest tumors and sympathetically innervated organs undergoing tissue sampling Experimental Treatment 1 Intervention

All subjects who undergo histopathologically established diagnosis of neuroblastoma and a scheduled clinical biopsy or surgery procedure within 21 days after 18F-mFBG PET imaging procedure; or be scheduled to have a clinical biopsy or surgery procedure that will yield a tissue specimen from an adrenergically-innervated organ or a non-neuroblastoma neural crest tumor within 21 days after 18F-mFBG PET imaging.

Who Is Running the Clinical Trial?

Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC)

Lead Sponsor

Trials

3

Recruited

60+

Albert Einstein College of Medicine

Collaborator

Trials

302

Recruited

11,690,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9931849/

[18F]mFBG PET-CT for detection and localisation of ... This pilot study investigates the feasibility of [ 18 F]mFBG PET-CT for imaging in neuroblastoma.

2. jnm.snmjournals.org jnm.snmjournals.org/content/66/supplement_1/251462

18F-mFBG PET in High-Risk Neuroblastoma Research experience with 18F-mFBG PET has consistently demonstrated increased detection of neuroblastoma lesions in bone and soft tissue ...

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

18F-meta-fluorobenzylguanidine (18F-mFBG) to monitor ... We investigate the potential of 18 F-mFBG, a positron emission tomography (PET) analogue of the 123 I-mIBG radiotracer, to quantify NET-1 expression levels in ...

4. jnm.snmjournals.org jnm.snmjournals.org/content/64/supplement_1/P608

The distinction of 18F-MFBG liver uptake in patients with ... 18 F-MFBG has shown promising diagnostic efficiency in neural crest tumors, especially in neuroblastoma with short time consuming and improved images.

5. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2025.1627403/full

Frontiers | [18F]mFBG PET/CT surpasses [18F]FDG PET/ ... Conclusion: [18F]mFBG PET/CT detected more neuroblastoma lesions than [18F]FDG PET/CT, suggesting it may be a more viable alternative when ...

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. 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 ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT04258592

Study Details | NCT04258592 | 18F-MFBG PET Imaging of ... A single dose of 18F-MFBG will be intravenously injected in 10 patients with neural crest tumors or neuroendocrine tumors. Adult patients will first undergo ...