18F-mFBG PET Imaging in the Evaluation of Neuroblastoma

NCT ID: NCT06852807

Last Updated: 2025-08-08

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-02-04
• Study Completion Date: 2029-12-31

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.

Conditions

Neuroblastoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

18F-MFBG PET/CT in Neuroblastoma

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.

18F-MFBG

Intervention Type: 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.

Interventions

18F-MFBG

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Peipei Wang, MD

Role: CONTACT

wpp199411@163.com

86 18511395988

Facility Contacts

Xinhui Su, MD

Role: primary

suxinhui@zju.edu.cn

86 13806071262

Peipei Wang, MD

Role: backup

wpp199411@163.com

86 18511395988

Other Identifiers

FAHZU-MFBG-NB

Identifier Type: -

Identifier Source: org_study_id