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

Last updated: November 13, 2024
Sponsor: Rigshospitalet, Denmark
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neuroblastoma

Treatment

18FmFBG imaging on the Large Field of View PET/CT (Total body PET/CT)

Clinical Study ID

NCT05826158
j. nr. H-21009982_v3
  • Ages < 18
  • All Genders

Study Summary

This is a study evaluating the positron-emitting radiopharmaceutical 18F-mFBG compared to 123I-mIBG scintigraphy for imaging of neuroblastoma

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. An established diagnosis of neuroblastoma based on unequivocal histopathology fromtissue obtained at any time prior to enrolment in the trial; OR b) A presumeddiagnosis of neuroblastoma based on signs, symptoms, physical examination, imagingfindings, and laboratory and genetic test results, including individuals in whomtherapy has already been empirically initiated.

  2. The subject has undergone or is scheduled to undergo evaluation of neuroblastomadisease status, including 123I-mIBG +/- 7 days to the date of 18F-mFBG imaging, withno therapy between such evaluation.

  3. Ability of subject or subject's legal guardian to understand and sign a writteninformed consent document.

Exclusion

  •   Exclusion Criteria:
  1. Pregnancy

Study Design

Total Participants: 25
Treatment Group(s): 1
Primary Treatment: 18FmFBG imaging on the Large Field of View PET/CT (Total body PET/CT)
Phase:
Study Start date:
June 06, 2022
Estimated Completion Date:
December 31, 2025

Study Description

This is a prospective study designed to assess the use of 18F-mFBG PET imaging compared to 123I-mIBG scintigraphy in subjects with known or presumed neuroblastoma. Eligible participants will have either histopathologically established diagnosis of neuroblastoma or a presumed diagnosis based on signs, symptoms, physical examination, imaging findings, and laboratory and genetic test results.

Subjects will only be administered 18F-mFBG if they have undergone or are scheduled to undergo a 123I-mIBG within +/- 7 days of the date of the 18F-mFBG scan. Subjects should not have received any chemotherapy, immunotherapy or radiotherapy between the clinical and 18F-mFBG imaging studies.

18F-mFBG PET studies will be evaluated by 2 independent teams of blinded readers: a nuclear medicine physician and a radiologist, both specialized in pediatric nuclear medicine co-reading side-by side.

The clinical 123I-mIBG is also evaluated by 2 independent teams of blinded readers: a nuclear medicine physician and a radiologist, both specialized in pediatric nuclear medicine co-reading side-by side.

Blinded readers will record whether findings on 18F-mFBG and 123I-mIBG scans are consistent with neuroblastoma.

Subject-level diagnostic performance will be assessed on the basis of differencies in lesion-counting between the blinded 18F-mFBG scan interpretation and the 123I-mIBG scan. In case of discrepancy, independently assessed by an Expert Panel.

Connect with a study center

  • Rigshospitalet, Copenhagen University Hospital

    Copenhagen, 2100
    Denmark

    Active - Recruiting

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