Actively Recruiting

Age: 0 - 18Years
All Genders
ID06852807

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

Led by First Affiliated Hospital of Zhejiang University · Updated on 2025-08-08

200

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate the use of 18F-metafluorobenzylguanidine (18F-MFBG) positron emission tomography (PET) in diagnosing neuroblastoma, a cancer that often expresses norepinephrine transporter (NET). The current imaging methods using radioactive iodine-labeled compounds have limitations such as low resolution, long procedures, and difficulty detecting small lesions. This study will look at the safety, image quality, and diagnostic ability of 18F-MFBG, which can be used shortly after injection and shows promise based on preliminary data. Participants will receive a single intravenous dose of 18F-MFBG at 2-5 MBq/kg. After 60 minutes, patients will undergo a PET/CT or PET/MR scan to visualize the tumor. This approach allows for quicker imaging compared to prior methods and aims to better detect neuroblastoma lesions. The study will compare this imaging technique's performance with other images and assess its value for predicting progression-free survival in high-risk patients. During the study, patients will be monitored for diagnostic efficacy over an average of 1.5 years, with secondary outcomes tracked for up to 3-4 years in some cases. Assessments include image quality, tumor burden evaluation, and safety observations. Participants will be involved in the injection and scanning procedures, with follow-up to assess prognosis and imaging performance. The total participation duration varies depending on outcome tracking needs.

CONDITIONS

Brief Title

18F-mFBG PET Imaging in the Evaluation of Neuroblastoma

Who Can Participate

Age: 0 - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 0-18 years old, with legal guardian
  • Clinically suspected or confirmed patients with neuroblastoma
  • If under 8 years old or unable to write, guardian must understand and comply with study requirements
  • If 8 years or older and able to write, both patient and guardian must sign informed consent
Not Eligible

You will not qualify if you...

  • Severe primary diseases such as heart, brain, liver, kidney, or blood system disorders
  • Ionizing radiation exposure exceeding 50 mSv in past year from other medical or research use
  • Use of experimental drugs or devices within one month prior to study
  • Any condition that may cause harm or risk related to trial as judged by principal investigator

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Single day

Participants receive a single intravenous injection of 18F-MFBG followed by a PET/CT or PET/MR scan approximately 60 minutes after injection to evaluate neuroblastoma lesions.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 3 to 4 years

Participants are monitored for diagnostic efficacy and progression-free survival over the course of the study.

Follow-up visits as needed over the monitoring period

Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China, 310003

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Research Team

P

Peipei Wang, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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