Evaluating 18F-MFBG PET Imaging for Neuroblastoma
Prospective Clinical Study of 18F-mFBG PET Imaging in Neuroblastoma
This study is testing a new type of PET scan using a special dye to see if it can help doctors better diagnose and understand the extent of neuroblastoma in patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | First Affiliated Hospital of Zhejiang University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06852807 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the diagnostic performance and tumor burden of 18F-metafluorobenzylguanidine (18F-MFBG) positron emission tomography (PET) in patients with neuroblastoma. Neuroblastoma is known to express norepinephrine transporter (NET), which 18F-MFBG targets effectively. The study will evaluate the safety profile, image quality, and diagnostic capabilities of 18F-MFBG, allowing for imaging to be performed shortly after injection without extensive preparation. Patients with suspected or confirmed neuroblastoma will be enrolled to determine the efficacy of this imaging technique.
Who should consider this trial
Good fit: Ideal candidates include children aged 0-18 years with suspected or confirmed neuroblastoma.
Not a fit: Patients with severe primary diseases or those who have received significant ionizing radiation recently may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more accurate and timely diagnostic tool for neuroblastoma, improving patient outcomes.
How similar studies have performed: Preliminary data suggest that similar imaging approaches have shown promise, but this specific use of 18F-MFBG is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Hangzhou, Zhejiang
- The First Affiliated Hospital of Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Peipei Wang, MD
- Email: wpp199411@163.com
- Phone: 86 18511395988
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.