Clinical trial NCT06852807: 18F-mFBG PET Imaging in the Evaluation of Neuroblastoma
Official title: Prospective Clinical Study of 18F-mFBG PET Imaging in Neuroblastoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neuroblastoma
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
First posted: 2025-02-28
Enrollment: 100
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with suspected or confirmed neuroblastoma

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.

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.

Primary outcomes:
measure: Diagnostic efficacy
timeFrame: through study completion, an average of 1.5 year
Secondary outcomes:
measure: 18F-mFBG PET performence compared with other images
timeFrame: up to 24 months
measure: Prognostic Value of Baseline 18F-mFBG PET for Progression-Free Survival (PFS) in High-Risk Patients
timeFrame: through study completion, 3-4 years
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The First Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References: