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

NCT06233903 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: IRP101-201
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Neuroblastoma; Pheochromocytoma; Paraganglioma

Outcome Measures

Primary Outcomes (2)

• Norepinephrine Transporter (NET) expression

  Norepinephrine Transporter (NET) expression of the sampled lesion(s)

  Tissue sampling completed within 22 days of 18F-mFBG imaging

• Quantitation of 18F-mFBG uptake in sampled tissue

  Standard Uptake Value (SUV) from PET images from specific anatomic regions sampled

  Analysis completed within 30 days of 18F-mFBG imaging

Secondary Outcomes (4)

• Comparison of results at 30 vs. 60 minutes

  30 days after completion of 18F-mFBG imaging (Day 0)

• Quality implications of reduced administered 18F-mFBG activity

  30 days after completion of 18F-mFBG imaging (Day 0)

• Comparison of 18F-mFBG disease detection at 60 minutes

  30 days after completion of 18F-mFBG imaging (Day 0)

• Occurrence of adverse events in subjects with neuroblastoma

  Up to 24 hours after each administration of 18F-mFBG injection

Study Arms (1)

Neural crest tumors and sympathetically innervated organs undergoing tissue sampling

EXPERIMENTAL

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.

Drug: 18F-mFBG

Interventions

18F-mFBG DRUG

18F-mFBG positron emission tomography with CT (PET/CT) or positron emission tomography with MRI (PET/MRI)

Also known as: Florbenguane F-18

Neural crest tumors and sympathetically innervated organs undergoing tissue sampling

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• I. 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.
• II. Non-neuroblastoma subjects (Cohort II):
• The subject is scheduled to undergo an invasive procedure (surgery or biopsy) to obtain tissue from an adrenergically-innervated organ or a neural crest tumor within 21 days after 18F-mFBG imaging.
• Histology specimens from the biopsy or surgical procedure are expected to be available and suitable for NET expression analyses.
• III. 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.

You may not qualify if:

• 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.
• Subjects will be eligible for participation in the study only if they meet ALL of the following criteria:
• I. 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.
• II. Non-neuroblastoma subjects (Cohort II)
• The subject is scheduled to undergo an invasive procedure (surgery or biopsy) to obtain tissue from an adrenergically-innervated organ or a neural crest tumor within 21 days after 18F-mFBG imaging.
• Histology specimens from the biopsy or surgical procedure are expected to be available and suitable for NET expression analyses.
• III. 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.
• Subjects will not be eligible for participation in the study if they meet ANY of the following criteria:
• Previously enrolled in this study.

Sponsors & Collaborators

• Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC): lead
• Albert Einstein College of Medicine: collaborator

Study Sites (1)

Montefiore Medical Center, Albert Einstein College of Medicine

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

Neuroblastoma; Pheochromocytoma; Paraganglioma

Interventions

3-fluorobenzylguanidine

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Neuroendocrine Tumors

Study Officials

• Alice Lee, MD

  Montefiore Medical Center/Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2024
• First Posted: January 31, 2024
• Study Start: January 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 21, 2025

Record last verified: 2025-01

Locations

US (1)