Comparing two imaging methods for evaluating neuroblastoma in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of 18F-mFBG PET imaging compared to 123I-mIBG scintigraphy in children diagnosed with neuroblastoma. Participants must have a confirmed or presumed diagnosis of neuroblastoma and will undergo both imaging techniques within a specified timeframe. The results will be analyzed by independent teams of specialists to determine the accuracy of each imaging method in identifying neuroblastoma. The goal is to assess which imaging technique provides better diagnostic performance.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. An established diagnosis of neuroblastoma based on unequivocal histopathology from tissue obtained at any time prior to enrolment in the trial; OR b) A presumed diagnosis of neuroblastoma based on signs, symptoms, physical examination, imaging findings, and laboratory and genetic test results, including individuals in whom therapy has already been empirically initiated.
2. The subject has undergone or is scheduled to undergo evaluation of neuroblastoma disease status, including 123I-mIBG +/- 7 days to the date of 18F-mFBG imaging, with no therapy between such evaluation.
3. Ability of subject or subject's legal guardian to understand and sign a written informed consent document.

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   Exclusion Criteria:

1\. Pregnancy

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Where it's running

• Rigshospitalet, Copenhagen University Hospital
  Copenhagen, Denmark Recruiting

Study contacts

• Principal investigator: Lise Borgwardt, MD, PhD. — Copenhagen University Hospital, Rigshospitalet
• Study coordinator: Lise Borgwardt, MD, PhD.
• Email: lise.borgwardt@regionh.dk
• Phone: +4535459568

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.