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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages N/A and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • I. Neuroblastoma subjects (Cohort I) 1.
The subject has an established diagnosis of neuroblastoma based on unequivocal histopathology from tissue obtained at any time prior to enrollment in the trial. 2. 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. 3. 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. 4. 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): 5.
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. 6. Histology specimens from the biopsy or surgical procedure are expected to be available and suitable for NET expression analyses.
  • III. All subjects: 7.
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:

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.

Inclusion Criteria:

Subjects will be eligible for participation in the study only if they meet ALL of the following criteria:
  • I. Neuroblastoma subjects (Cohort I) 1.
The subject has an established diagnosis of neuroblastoma based on unequivocal histopathology from tissue obtained at any time prior to enrollment in the trial. 2. 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. 3. 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. 4. 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) 5.
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. 6. Histology specimens from the biopsy or surgical procedure are expected to be available and suitable for NET expression analyses.
  • III. All subjects.
7. 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: 1. Previously enrolled in this study. 2. Unable to lie flat or remain still for approximately 30 minutes to allow performance of a PET scan. 3. The subject has a history or suspicion of significant allergic reaction or anaphylaxis to any components of the 18F-mFBG imaging agent. 4. The subject is pregnant, breast feeding, or menarchal and unwilling to use effective contraception during the study. 5. 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06233903
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC)
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Alice Lee, MD
Principal Investigator Affiliation Montefiore Medical Center/Albert Einstein College of Medicine
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry, Other
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Neuroblastoma, Pheochromocytoma, Paraganglioma
Additional Details

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.

Arms & Interventions

Arms

Experimental: Neural crest tumors and sympathetically innervated organs undergoing tissue sampling

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.

Interventions

Drug: - 18F-mFBG

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Bronx, New York

Status

Address

Montefiore Medical Center, Albert Einstein College of Medicine

Bronx, New York, 10467

Site Contact

Alice Lee, MD

[email protected]

718-741-2342

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