18F-mFBG PET Imaging in the Evaluation of Neuroblastoma

Recruiting

• Conditions: Neuroblastoma
• Interventions: Drug: 18F-MFBG

• Registration Number: NCT06852807
• Lead Sponsor: First Affiliated Hospital of Zhejiang University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2025-01
• Study Start: 2025-02-04
• Study First Submitted: 2025-02-04
• Study First Submitted QC: 2025-02-24
• Last Update Submitted: 2025-02-24
• Study First Posted: 2025-02-28
• Last Update Posted: 2025-02-28
• Primary Completion: 2027-12
• Study Completion: 2029-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Age 0-18 years old, with legal guardian;
2. Clinically suspected or confirmed patients with neuroblastoma;
3. 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

1. Patients with severe primary diseases such as heart, brain, liver, kidney and hematopoietic system diseases;
2. 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.
3. Patients who have received experimental drugs or devices (with uncertain efficacy or safety) within one month;
4. 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
18F-MFBG PET/CT in Neuroblastoma	18F-MFBG	Each patient receive a single intravenous injection of 18F-MFBG 2-5 MBq/kg and undergo PET/CT or PET/MR scan after 60 min post-injection.

Primary Outcome Measures

Name	Time	Method
Diagnostic efficacy	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 Outcome Measures

Name	Time	Method
18F-mFBG PET performence compared with other images	up to 24 months	18F-mFBG PET performence compared with 18F-FDG PET or MRI, McNemar test, Two-tailed，P\<.05
Prognostic Value of Baseline 18F-mFBG PET for Progression-Free Survival (PFS) in High-Risk Patients	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.

Trial Locations

Locations (1)

The First Affiliated Hospital of Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China