18F-mFBG PET Imaging in the Evaluation of Neuroblastoma

NCT06852807 | Recruiting

• 1 other identifier: FAHZU-MFBG-NB
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuroblastoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 18F-mFBG PET performence compared with other images

  up to 24 months

• Prognostic Value of Baseline 18F-mFBG PET for Progression-Free Survival (PFS) in High-Risk Patients

  through study completion, 3-4 years

Study Arms (1)

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.

Drug: 18F-MFBG

Interventions

18F-MFBG 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.

18F-MFBG PET/CT in Neuroblastoma

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

patients with suspected or confirmed neuroblastoma

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead

Study Sites (1)

The First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

RECRUITING

MeSH Terms

Conditions

Neuroblastoma

Interventions

3-fluorobenzylguanidine

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Central Study Contacts

Peipei Wang, MD

CONTACT

86 18511395988; wpp199411@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2025
• First Posted: February 28, 2025
• Study Start: February 4, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2029
• Last Updated: August 8, 2025

Record last verified: 2025-01

Locations

CN (1)