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NCT Number: NCT06852807

18F-mFBG PET Imaging in the Evaluation of Neuroblastoma

The aim of this study is to evaluate the diagnostic performance and tumor burden of 18F-metafluorobenzylguanidine (18F-MFBG) positron emission tomography (PET) in patients with neuroblastoma.

Recruiting

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Key information

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

Neuroblastoma highly expresses norepinephrine transporter (NET) which is targeted by function alanalogue of norepinephrine, 123/131I-MlBG. However, low spatial resolution of 123/131I-MlBG and inaccurate attenuation correction of single photon emission tomography (SPECT/CT) will affect the image quality of MlBG SPECT and lead to poor diagnosis of small lesions. In addition, 123l-MlBG imaging is usually performed at 24h after injection, while 131I-MlBG is performed at 48h or even 72h after injection. The procedure is complicated and takes a long time, which limits clinical application. 18F-labeled MFBG is an ideal tracer to show the expression of NET. Preliminary data show that 18F-MFBG imaging is safe and has favorable biodistribution and kinetics with good targeting of lesions. Patients can undergo PET 0.5 hours after injection without special preparation. Our study will assess the safety profile, image quality and evaluate the diagnostic performance and tumor burden of 18F-MFBG. Patients with suspected or histologically confirmed neuroblastoma will be enrolled in this study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 0-18 years old, with legal guardian;
  • Clinically suspected or confirmed patients with neuroblastoma;
  • If the patient is under 8 years old or unable to write, his/her guardian should understand and comply with the requirements of the study. If the patient is 8 years old or older and has written ability, both the patient and his/her guardian must sign the informed consent.

Exclusion criteria

  • Patients with severe primary diseases such as heart, brain, liver, kidney and hematopoietic system diseases;
  • Patients who have received ionizing radiation outside the scope of this experiment for other clinical medical or scientific research purposes within the past year, resulting in an annual radiation exposure dose exceeding 50 mSv.
  • Patients who have received experimental drugs or devices (with uncertain efficacy or safety) within one month;
  • Patients with any condition that the principal investigator of this study deems may cause harm or potential harm in any aspect related to this trial.

Treatment and study plan

18F-MFBG

Drug

Patients with neuroblastoma malignancies receive 5.55 MBq/kg of 18F-MFBG intravenously followed by PET/CT or PET/MR after 60min of injection.

Primary outcomes

  1. Diagnostic efficacy

    Time frame: through study completion, an average of 1.5 year

    Sensitivity, specificity, positive and negative predictive value of 18F-mFBG PET/CT and PET/MR Imaging in neuroblastoma

Secondary outcomes

  1. 18F-mFBG PET performence compared with other images

    Time frame: up to 24 months

    18F-mFBG PET performence compared with 18F-FDG PET or MRI, McNemar test, Two-tailed,P<.05

  2. Prognostic Value of Baseline 18F-mFBG PET for Progression-Free Survival (PFS) in High-Risk Patients

    Time frame: through study completion, 3-4 years

    This measure evaluates the association between baseline 18F-mFBG PET parameters (e.g., SUVmax, SUVmean, metabolic tumor volume [MTV], total lesion glycolysis [TLG]) and progression-free survival (PFS) in high-risk neuroblastoma patients. PFS will be defined as the time from diagnosis to disease progression or relapse, assessed using the Kaplan-Meier method and Cox proportional hazards model.

Study contacts

Contact information is provided by the study sponsor or research team.

Peipei Wang, MD

CONTACT

[email protected]

86 18511395988

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Zhejiang University

Other

Registry information

Official study title

Prospective Clinical Study of 18F-mFBG PET Imaging in Neuroblastoma

Important dates

Study start
2025
Primary completion
2027
Study completion
2029
First posted
Feb 28, 2025
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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