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Clinical Trial NCT06852807 for Neuroblastoma is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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18F-mFBG PET Imaging in the Evaluation of Neuroblastoma 200

Recruiting
Clinical Trial NCT06852807 is an observational study for Neuroblastoma that is recruiting. It started on 4 February 2025 with plans to enroll 200 participants. Led by First Affiliated Hospital of Zhejiang University, it is expected to complete by 1 December 2029. The latest data from ClinicalTrials.gov was last updated on 8 August 2025.
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 24...Show More
Official Title

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

Conditions
Neuroblastoma
Other Study IDs
  • FAHZU-MFBG-NB
NCT ID Number
NCT06852807
Start Date (Actual)
2025-02-04
Last Update Posted
2025-08-08
Completion Date (Estimated)
2029-12
Enrollment (Estimated)
200
Study Type
Observational
Status
Recruiting
Arms / Interventions
Participant Group/ArmIntervention/Treatment
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
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 Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Diagnostic efficacy
Sensitivity, specificity, positive and negative predictive value of 18F-mFBG PET/CT and PET/MR Imaging in neuroblastoma
through study completion, an average of 1.5 year
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
18F-mFBG PET performence compared with other images
18F-mFBG PET performence compared with 18F-FDG PET or MRI, McNemar test, Two-tailed，P\<.05
up to 24 months
Prognostic Value of Baseline 18F-mFBG PET for Progression-Free Survival (PFS) in High-Risk Patients
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.
through study completion, 3-4 years
Participation Assistant
Eligibility Criteria

Eligible Ages
Child, Adult
Eligible Sexes
All
  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.

  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.
First Affiliated Hospital of Zhejiang University logoFirst Affiliated Hospital of Zhejiang University
Study Central Contact
Contact: Peipei Wang, MD, 86 18511395988, [email protected]
1 Study Locations in 1 Countries

Zhejiang

The First Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310003, China
Xinhui Su, MD, Contact, 86 13806071262, [email protected]
Peipei Wang, MD, Contact, 86 18511395988, [email protected]
Recruiting