18F-mFBG Imaging for Neural Crest Tumors

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

Trial Summary

What is the purpose of this trial?

This is a prospective Phase 2 study being performed to document the relationship between 18F-mIBG positron emission tomography (PET) findings in subjects, and expression of the norepinephrine transporter. In addition to collecting safety data for the imaging agent, the study aims to: * compare the findings against other catacholamine transporters * evaluate the imaging results at different time points and in different organs * assess the quality of images with lower doses * compare the ability to detect neuroblastoma lesions against other imaging agents, and in other tumors

Research Team

Alice Lee, MD

Principal Investigator

Montefiore Medical Center/Albert Einstein College of Medicine

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+