← Back to Search

Neural crest tumors and sympathetically innervated organs undergoing tissue sampling for Neuroblastoma

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.

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Norepinephrine Transporter (NET) expression

Quantitation of 18F-mFBG uptake in sampled tissue

Secondary outcome measures

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

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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

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

2 Previous Clinical Trials

63 Total Patients Enrolled

1 Trials studying Neuroblastoma

43 Patients Enrolled for Neuroblastoma

Albert Einstein College of MedicineOTHER

286 Previous Clinical Trials

11,856,952 Total Patients Enrolled

1 Trials studying Neuroblastoma

132 Patients Enrolled for Neuroblastoma

Alice Lee, MDPrincipal InvestigatorMontefiore Medical Center/Albert Einstein College of Medicine

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of individuals being recruited for participation in this clinical study?

"Indeed, the information available on clinicaltrials.gov indicates that this ongoing clinical trial is actively seeking eligible participants. The study was initially posted on September 14th, 2023 and underwent its most recent update on January 30th, 2024. Recruitment for this study aims to enroll a total of 29 patients from a single research site."

Answered by AI

Are potential participants currently able to apply for this ongoing medical study?

"Indeed, as per the details available on clinicaltrials.gov, this research is presently seeking suitable candidates. The initial posting of this clinical trial was made on September 14th, 2023, and it has been recently updated on January 30th, 2024. This study aims to enroll a total of 29 participants across a single designated site."

Answered by AI

What are the main goals being pursued in this research endeavor?

"The primary objective of this study is to measure the uptake of 18F-mFBG in sampled tissue, with tissue sampling completed within 22 days of imaging. Secondary outcomes include evaluating the quality implications of reducing the administered activity of 18F-mFBG and comparing disease detection at 60 minutes between different imaging methods. The image data files and processed PET images will undergo blinding and randomization before being qualitatively examined by three independent readers who are unaware of the clinical status but have access to cross-sectional images (CT or MRI) acquired during the PET exam. Additionally, adverse events occurring in subjects with neuroblastoma will be"

Answered by AI

What is the level of safety associated with obtaining tissue samples from neural crest tumors and sympathetically innervated organs in individuals?

"The safety of Neural crest tumors and sympathetically innervated organs undergoing tissue sampling is estimated to be a 2 on a scale from 1 to 3. This evaluation corresponds to the Phase 2 trial, which has limited data supporting safety but no evidence yet for efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

18F-mFBG Expression in Neural Crest Tumors and Organs Innervated by the Sympathetic Nervous System

2024. "18F-mFBG Expression in Neural Crest Tumors and Organs Innervated by the Sympathetic Nervous System". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06233903.

All > Paraganglioma > Neuroblastoma