NCT06233903

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

A Prospective Study Assessing the Relationship Between Expression of the Norepinephrine Transporter and 18F-mFBG PET Imaging Results in Neuroblastoma Tumor, Other Neural Crest Tumors, and Organs Innervated by the Sympathetic Nervous System

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC) · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This is a prospective, Phase 2, open-label study designed to assess the relationship of 18F- mFBG PET imaging findings and NET expression in neuroblastoma tumor (Cohort I) and adrenergically-innervated organs in non-tumor subjects or neural crest tumors other than neuroblastoma (e.g. pheochromocytoma/paraganglioma) (Cohort II). As the mechanism of cellular uptake of benzylguanidine compounds such as mFBG is predominantly via cell-surface NET, there should be a demonstrable relationship between level of NET expression, whether expressed on neuroblastoma tumor, other neural crest tumors, or organs innervated by sympathetic neurons, and 18F-mFBG PET results. Eligible participants will either have: 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. At least one tissue specimen must be expected to be suitable for analysis of NET expression. Every subject will be expected to have at least 1 suitable recent tissue specimen available for NET expression analysis. Neuroblastoma subjects will also have undergone at least 1 exam with the current standard of care benzylguanidine imaging agent, 123I-mIBG, during the course of clinical care following the original diagnosis of neuroblastoma. All subjects will undergo 18F-mFBG PET imaging using either clinical PET/CT or PET/MRI equipment. PET studies will be examined on-site by a board-certified nuclear medicine physician or a board-certified radiologist experienced in reading 123I-mIBG and PET scans to ensure technical image quality and information content.

Conditions

• Neuroblastoma
• Pheochromocytoma
• Paraganglioma

Interventions

Type	Name	Description
DRUG	18F-mFBG	18F-mFBG positron emission tomography with CT (PET/CT) or positron emission tomography with MRI (PET/MRI)

Timeline

• Start date: 2025-01-01
• Primary completion: 2025-09-01
• Completion: 2025-12-01
• First posted: 2024-01-31
• Last updated: 2025-01-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study