NCT06858501

Comparing 123I-MIBG and 18F-MFBG Imaging in Patients With Newly Diagnosed, High Risk Neuroblastoma

Concordance in Response Assessment Incorporating Meta-Iodobenzylguanidine (123I-MIBG) and Meta-[18F]Fluorobenzylguanidine (18F-MFBG, IND#146379, NSC#853868) Imaging in Neuroblastoma

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: Children's Oncology Group · Network
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This phase II trial evaluates whether an investigational scan (18F-MFBG positron emission tomography \[PET\]/computed tomography \[CT\] or PET/magnetic resonance imaging \[MRI\]) can accurately detect tumors in patients with newly diagnosed, high-risk neuroblastoma as well as standard of care imaging with 123 I-MIBG. 18F-MFBG is a radioactive diagnostic agent that is injected into a vein and taken up by tumor cells. The cells can then be visualized using PET/CT or PET/MRI scans. A PET scan uses radioactive material injected into the blood to show the internal workings of the body. A CT scan uses x-rays and a computer to produce a 3-dimensional image of the body. MRI uses radiofrequency waves and a strong magnetic field rather than x-rays to provide clear and detailed pictures of internal organs and tissues. Combining PET with CT or MRI may help doctors better understand the extent and the exact location of disease. Diagnostic procedures, such as 18F-MFBG PET/CT or PET/MRI, may detect tumors as well as or better than the current standard imaging with 123 I-MIBG in patients with newly diagnosed, high-risk neuroblastoma.

Detailed description

PRIMARY OBJECTIVE: I. To estimate the concordance in International Neuroblastoma Response Criteria (INRC) response designations at the end of induction as assessed by iobenguane I-123 (123I-MIBG) and florbenguane F18 (18F-MFBG) central reads in patients with high-risk stage L2 and stage M neuroblastoma. SECONDARY OBJECTIVES: I. To describe individual metastatic lesion response using 123I-MIBG and 18F-MFBG imaging at diagnosis and end-induction. II. To describe concordance in central Curie score between 123I-MIBG and 18F-MFBG imaging. III. To describe concordance in end of induction response designations (poor end-of induction response versus \[vs.\] good end-of induction response) as assessed by 123I-MIBG and 18F-MFBG in patients receiving high-risk therapy. IV. To describe concordance as assessed by 123I-MIBG and 18F-MFBG in the INRC components of primary (soft tissue) tumor response and tumor response at metastatic soft tissue and bone sites in patients receiving high-risk therapy. EXPLORATORY OBJECTIVES: I. To describe concordance in International Neuroblastoma Risk Group Staging System (INRGSS) stage as assessed by 123I-MIBG and 18F-MFBG. II. To describe the natural history of discordant lesions detected only by 18F-MFBG and not by 123I-MIBG in patients with high-risk neuroblastoma, and to describe additional interventions undertaken (including additional imaging, biopsies, and/or additional therapies) based on identification of discordant lesions. III. To describe the change in standardized uptake value (SUV) of the primary and metastatic lesions on 18F-MFBG scans from diagnosis to end of induction. IV. To evaluate the patient/family experience with 123I-MIBG and 18F-MFBG imaging. V. To describe concordance between detection of disease using 123I-MIBG imaging (Curie score), 18F-MFBG imaging (Curie score) and the percentage of circulating tumor deoxyribonucleic acid (DNA) (as a continuous variable) testing during high-risk neuroblastoma therapy. VI. To identify logistical barriers to successful imaging using 18F-MFBG. VII. To quantify inter-observer variability of Curie scores on 18F-MFBG and 123I-MIBG among central reviewers. VIII. To describe acute toxicity of 18F-MFBG administration. IX. To estimate the progression free survival (PFS) and overall survival (OS) among eligible patients enrolled on the study. OUTLINE: Patients receive 18F-MFBG intravenously (IV) over 1 minute and undergo PET/CT or PET/MRI over 9-30 minutes at the time of each standard of care (SOC) 123I-MIBG scan (at the time of induction cycle 1, at the end of the last induction cycle, and at the time of first relapse/disease progression). Patients may undergo blood sample collection throughout the study.

Conditions

• Ganglioneuroblastoma
• Ganglioneuroblastoma, Nodular
• High Risk Neuroblastoma

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo blood sample collection
PROCEDURE	Computed Tomography	Undergo PET/CT
RADIATION	Florbenguane F18	Given IV
PROCEDURE	Magnetic Resonance Imaging	Undergo PET/MRI
PROCEDURE	Positron Emission Tomography	Undergo PET/CT or PET/MRI
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2026-06-22
• Primary completion: 2028-12-20
• Completion: 2028-12-20
• First posted: 2025-03-05
• Last updated: 2026-03-19

Regulatory

• FDA-regulated drug study