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18F-mFBG Imaging for Neural Crest Tumors

Phase 2

Waitlist Available

Led By Alice Lee, MD

Research Sponsored by Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Neuroblastoma subjects (Cohort I): The subject has an established diagnosis of neuroblastoma based on unequivocal histopathology from tissue obtained at any time prior to enrollment in the trial. Functional imaging (123I-mIBG or 18F-FDG) studies performed within 60 days prior to receiving investigational drug in the trial are available for retrieval and independent review. The subject is scheduled to undergo an invasive procedure (surgery or biopsy) for diagnosis or therapy of neuroblastoma within 21 days after receiving investigational drug in the trial, with no therapy in the interval between 18F-mFBG imaging and surgery/biopsy. Histology specimens from the biopsy or surgical procedure are expected to be available and suitable for NET expression analyses.

Must not have

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.

Study Population: The population will consist of either: subjects with histopathologically confirmed diagnosis of neuroblastoma; or subjects with a clinical indication for biopsy or surgical sampling of an adrenergically-innervated organ or a non-neuroblastoma neural crest tumor.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 hours after each administration of 18f-mfbg injection

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying the relationship between a type of imaging called 18F-mIBG positron emission tomography (PET) and a transporter in the body called norepinephrine transporter.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial focuses on an imaging agent used in PET scans rather than a treatment drug, typical side effects may include discomfort from injection of the tracer and potential allergic reactions but are generally minimal.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 hours after each administration of 18f-mfbg injection

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 hours after each administration of 18f-mfbg injection

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 hours after each administration of 18f-mfbg injection for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Norepinephrine Transporter (NET) expression

Quantitation of 18F-mFBG uptake in sampled tissue

Secondary study objectives

Comparison of 18F-mFBG disease detection at 60 minutes

Comparison of results at 30 vs. 60 minutes

Occurrence of adverse events in subjects with neuroblastoma

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Neural crest tumors and sympathetically innervated organs undergoing tissue samplingExperimental Treatment1 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.

0 / 3Eligibility criteria met