Actively Recruiting

Age: 0 - 18Years
All Genders
ID06852807

Prospective Clinical Study of 18F-mFBG PET Imaging in Neuroblastoma to Evaluate Diagnostic Performance and Tumor Burden

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

200

Participants Needed

1

Research Sites

251 weeks

Total Duration

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AI-Summary

What this Trial Is About

Researchers are evaluating the diagnostic performance and tumor burden detection of 18F-metafluorobenzylguanidine (18F-MFBG) positron emission tomography (PET) in patients with neuroblastoma, a cancer that highly expresses norepinephrine transporter (NET). Current imaging methods using 123/131I-MIBG have limitations such as low image resolution and lengthy procedures. The study aims to assess the safety, image quality, and diagnostic accuracy of 18F-MFBG PET, which can be performed quickly after injection and may improve detection of small lesions. In this study, patients with suspected or confirmed neuroblastoma will receive an intravenous dose of 5.55 MBq/kg of 18F-MFBG. After 60 minutes, participants will undergo PET/CT or PET/MR imaging to evaluate tumor presence and burden. The use of 18F-MFBG allows imaging to begin as soon as 0.5 hours after injection without special preparation, potentially offering a more convenient and effective diagnostic option. Participants will be involved in imaging and monitoring procedures lasting an average of 1.5 years to assess the diagnostic efficacy of 18F-MFBG PET. Researchers will evaluate safety profiles, scan image quality, and tumor burden measurements throughout the study period. This ongoing observation aims to provide comprehensive data on the performance of this imaging method in detecting neuroblastoma tumors.

CONDITIONS

Official 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 to 18 years old with a legal guardian
  • Clinically suspected or confirmed neuroblastoma
  • If under 8 years old or unable to write, guardian must understand and comply with study requirements
  • If 8 years old 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 diseases
  • Ionizing radiation exposure exceeding 50 mSv in the past year outside this study
  • Use of experimental drugs or devices within the past month
  • Any condition deemed potentially harmful by the principal investigator

AI-Screening

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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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