Actively Recruiting

Phase Not Applicable
Age: 0 - 18Years
All Genders
ID05826158

18F-mFBG PET/CT Compared to 123I-mIBG Scintigraphy SPECT/CT for Imaging Neuroblastoma in Children

Led by Rigshospitalet, Denmark · Updated on 2024-11-15

25

Participants Needed

1

Research Sites

186 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating a new imaging method called 18F-mFBG PET compared to the standard 123I-mIBG scintigraphy to detect neuroblastoma in children. This study includes participants with either a confirmed diagnosis of neuroblastoma through tissue tests or a presumed diagnosis based on symptoms, physical exams, imaging, and lab tests. The goal is to assess how well the 18F-mFBG PET scan identifies neuroblastoma compared to the current standard imaging technique. Participants will undergo both 18F-mFBG PET and 123I-mIBG scintigraphy scans within a week of each other, with no chemotherapy, immunotherapy, or radiotherapy given between the two imaging tests. The 18F-mFBG PET scans are performed using a large field of view PET/CT scanner that covers the whole body. Expert teams, including nuclear medicine physicians and radiologists who specialize in pediatric nuclear medicine, will independently review the scans without knowing the other results to compare findings. During the study, researchers will analyze the scans to see if they consistently detect neuroblastoma and compare the number of lesions found by each imaging method. If there are differences, an expert panel will review the cases. Participants or their guardians will give informed consent before joining, and the study focuses on children up to 18 years old. The main outcome is the accuracy of the 18F-mFBG PET scan in identifying neuroblastoma lesions compared to the 123I-mIBG scan.

CONDITIONS

Official Title

18F-mFBG LAFOV PET/CT Compared to 123I-mIBG Scintigraphy SPECT/CT for Evaluation of Children With Neuroblastoma

Who Can Participate

Age: 0 - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • An established diagnosis of neuroblastoma based on tissue biopsy at any time before the trial; OR a presumed diagnosis based on symptoms, physical exam, imaging, lab, and genetic tests, including those already receiving treatment.
  • The participant has had or will have a 123I-mIBG scan within 7 days before or after the 18F-mFBG scan, with no treatment between scans.
  • The participant or legal guardian can understand and sign informed consent.
Not Eligible

You will not qualify if you...

  • Pregnancy

AI-Screening

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Trial Site Locations

Total: 1 location

1

Rigshospitalet, Copenhagen University Hospital

Copenhagen, Denmark, 2100

Actively Recruiting

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Research Team

L

Lise Borgwardt, MD, PhD.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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Published Research Related To This Trial

Performing [18F]MFBG Long-Axial-Field-of-View PET/CT Without Sedation or General Anesthesia for Imaging of Children with Neuroblastoma.

Lise Borgwardt, Jesper Brok, Kim Francis Andersen...

https://pubmed.ncbi.nlm.nih.gov/38960713