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NeuroblastomaPhase 2NCT06233903

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

A Phase 2 study testing 18F-mFBG in people with Neuroblastoma and Pheochromocytoma, run by Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC) at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Neuroblastoma, Pheochromocytoma, Paraganglioma
What is being tested?
18F-mFBG
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Jan 2025to Dec 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.
  • Non-neuroblastoma subjects (Cohort II):
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  • 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.
  • 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 be eligible for participation in the study only if they meet ALL of the following criteria:
  • 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.
  • 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.
  • 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.

Who cannot join

  • 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 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Montefiore Medical Center, Albert Einstein College of Medicine

    The Bronx, New York, 10467

Other trials in United States

About this study

Official title: 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

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
Read the 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.

Being tested
18F-mFBG
Medical subject headings
Neuroblastoma, Pheochromocytoma, Paraganglioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 18F-mFBGDrug

    Also called Florbenguane F-18

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

Study groups in NCT06233903
Study groupRoleWhat they receive
Neural crest tumors and sympathetically innervated organs undergoing tissue samplingExperimentalAll 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.
Receives: Drug: 18F-mFBG

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Norepinephrine Transporter (NET) expression

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

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

  2. Quantitation of 18F-mFBG uptake in sampled tissue

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

    Measured: Analysis completed within 30 days of 18F-mFBG imaging

Secondary outcomes (4)

  1. Comparison of results at 30 vs. 60 minutes

    To evaluate whether 18F-mFBG imaging at 30 min yields results equivalent to those at 60 min post-injection. All image data files and processed/reconstructed PET images will undergo blinding and randomization. 18F-mFBG images will be qualitatively examined by 3 independent readers with no knowledge of the clinical status of the subjects but with access to anatomic cross-sectional images (CT or MRI) acquired as part of the PET exam.

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

  2. Quality implications of reduced administered 18F-mFBG activity

    To assess the image quality implications of reducing the administered activity of 18F-mFBG. All image data files and processed/reconstructed PET images will undergo blinding and randomization. 18F-mFBG images will be qualitatively examined by 3 independent readers with no knowledge of the clinical status of the subjects but with access to anatomic cross-sectional images (CT or MRI) acquired as part of the PET exam. On-site image assessments will be performed per standard practice for PET imaging at the investigational site. Data for the on-site interpretations will be collected.

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

  3. Comparison of 18F-mFBG disease detection at 60 minutes

    To determine if 18F-mFBG imaging at 60 min detects more neuroblastoma lesions than 123I-mIBG or 18F-FDG imaging. All image data files and processed/reconstructed PET images will undergo blinding and randomization. 18F-mFBG images will be qualitatively examined by 3 independent readers with no knowledge of the clinical status of the subjects but with access to anatomic cross-sectional images (CT or MRI) acquired as part of the PET exam.

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

  4. Occurrence of adverse events in subjects with neuroblastoma

    To collect safety data on 18F-mFBG

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2024
  2. Study startJan 2025 (estimated)
  3. Primary completionSep 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Why it stopped: Logistical considerations

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06233903
Sponsor's protocol ID
IRP101-201
Status last verified
Jan 2025
First submitted
5 Jan 2024
Last updated
21 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 18F-mFBG in people with Neuroblastoma and Pheochromocytoma, run by Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 21 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Norepinephrine Transporter (NET) expression (time frame: Tissue sampling completed within 22 days of 18F-mFBG imaging). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06233903.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2025.

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