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

NCT05826158 | Recruiting DMC

• 1 other identifier: j. nr. H-21009982_v3
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Neuroblastoma

Keywords

18F-mFBG; meta-fluorobenzylguanidine; Large Axial Field of View PET/CT, LAFOV PET/CT; Total body PET/CT

Outcome Measures

Primary Outcomes (1)

• 18F-mFBG PET Scan identification of Neuroblastoma on the LAFOV PET/CT

  Pathological 18F-mFBG uptake when imaging after 60 minutes with LAFOV PET/CT

  60 minutes

Secondary Outcomes (1)

• Comparison of 18F-mFBG with Clinical 123I-mIBG imaging

  7 days apart

Study Arms (1)

Children with Neuroblastoma

OTHER

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

Interventions

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

18F-mFBG imaging on the Large Field of View PET/CT (Total body PET/CT)

Children with Neuroblastoma

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• 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.
• Ability of subject or subject's legal guardian to understand and sign a written informed consent document.

You may not qualify if:

• \. Pregnancy

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet, Copenhagen University Hospital

Copenhagen, 2100, Denmark

RECRUITING

MeSH Terms

Conditions

Neuroblastoma

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Lise Borgwardt, MD, PhD.

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Borgwardt, MD, PhD.

CONTACT

+4535459568; lise.borgwardt@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant Ph.D.

Study Record Dates

• First Submitted: April 11, 2023
• First Posted: April 24, 2023
• Study Start: June 6, 2022
• Primary Completion: September 1, 2025
• Study Completion: December 31, 2025
• Last Updated: November 15, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)