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

NCT06858501 | Not Yet Recruiting Phase 2 FDA Drug

• 3 other identifiers: PEPN24N1NCI-2025-00042UM1CA228823
• Study Type: interventional
• Target: 84
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Ganglioneuroblastoma, Nodular; High Risk Neuroblastoma; Ganglioneuroblastoma

Outcome Measures

Primary Outcomes (1)

• Concordance in International Neuroblastoma Response Criteria (INRC) objective response measures

  Will be estimated with 95% confidence intervals (CIs) using the unweighted kappa coefficient at each of the three time points.

  Up to 105 days

Secondary Outcomes (4)

• Individual metastatic lesion response

  Up to 105 days

• Curie scores

  Up to 3 years

• Concordance in end of induction response

  Up to 105 days

• Concordance in 123I-MIBG and 18F-MFBG scans by INRC components

  Up to 105 days

Other Outcomes (11)

• Concordance in International Neuroblastoma Risk Group Staging System (INRGSS) stage

  Up to 3 years

• Natural history of discordant lesions

  Up to 3 years

• Additional interventions undertaken based on identification of discordant lesions

  Up to 3 years

Study Arms (1)

Diagnostic (18F-MFBG)

EXPERIMENTAL

Patients receive 18F-MFBG IV over 1 minute and undergo PET/CT or PET/MRI over 9-30 minutes at the time of each 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.

Procedure: Biospecimen Collection; Procedure: Computed Tomography; Radiation: Florbenguane F18; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography; Other: Questionnaire Administration

Interventions

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Diagnostic (18F-MFBG)

Computed Tomography PROCEDURE

Undergo PET/CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, Diagnostic CAT Scan, Diagnostic CAT Scan Service Type, tomography

Diagnostic (18F-MFBG)

Florbenguane F18 RADIATION

Given IV

Also known as: 18F meta-Fluoro Benzylguanidine, 18F-MFBG, [(18)F]-MFBG, Florbenguane (18F), FLORBENGUANE F-18, IRP 101, IRP-101, meta-[(18)F]-Fluorobenzylguanidine, meta-Fluorine F 18 Fluorobenzylguanidine, Meta-fluoro Benzylguanidine F-18

Diagnostic (18F-MFBG)

Magnetic Resonance Imaging PROCEDURE

Undergo PET/MRI

Also known as: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI

Diagnostic (18F-MFBG)

Positron Emission Tomography PROCEDURE

Undergo PET/CT or PET/MRI

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT

Diagnostic (18F-MFBG)

Questionnaire Administration OTHER

Ancillary studies

Diagnostic (18F-MFBG)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Any age at diagnosis.
• Patients must have a diagnosis of neuroblastoma or ganglioneuroblastoma (nodular, unfavorable subtype) verified by tumor pathology analysis or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites.
• Patients must have high-risk neuroblastoma defined as one of the following:
• Any age with International Neuroblastoma Risk Group (INRG) stage L2 or M and MYCN amplification.
• Age ≥ 547 days and INRG stage M regardless of biologic features.
• Age ≥ 547 days and INRG stage L2 with unfavorable histology.
• Patients must have newly diagnosed disease.
• Patients must have either measurable or evaluable disease by INRC.
• Patients observed or treated with a single cycle of chemotherapy per a low- or intermediate-risk neuroblastoma regimen (e.g. as per ANBL0531, ANBL1232 or similar) for what initially appeared to be non-high-risk disease, but subsequently found to meet high-risk criteria will be eligible. These patients must enroll prior to the start of high-risk therapy.
• Patients who receive localized emergency radiation to sites of life-threatening or function-threatening disease prior to or immediately after establishment of the definitive diagnosis will be eligible.
• Patients initially recognized to have high-risk disease must enroll prior to or within the first week after starting high-risk induction chemotherapy.
• Induction therapy as per a standard high-risk neuroblastoma induction regimen (examples include ANBL1531 arm A, ANBL2131 arm A, or ANBL2131 arm B) must be planned for patients to be eligible for this study.

You may not qualify if:

• Pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events of radiation. Pregnancy tests must be obtained in girls who are post-menarchal. Males or females of reproductive potential may not participate unless they have agreed to use two effective methods of birth control, including a medically accepted barrier or contraceptive method (e.g., male or female condom) at least 48 hours prior to and following all imaging studies. Abstinence is an acceptable method of birth control.
• Norepinephrine transporter (NET)-dependent agents: Many medications are known to interfere with uptake of NET-dependent agents. Investigators should use caution when prescribing these medications for patients undergoing procedures on this study. Medications that are known to substantially interfere with uptake of NET-dependent agents should be held if possible, based on patient condition 24 hours prior to each 18F-MFBG scan. These agents can be resumed immediately after each 18F-MFBG scan is completed. Patients who are receiving medications that are known to significantly interfere with uptake of NET-dependent agents (primarily tricyclic antidepressants, psychostimulants, and antihypertensives) and for whom these medications cannot be safely withheld before the start of study procedures will not be eligible.
• The patient has a known or suspected history of significant allergic reaction or anaphylaxis to any components of the 18F-MFBG or 123I-MIBG imaging agents.
• Patients who will require sedation or anesthesia only for 18F-MFBG imaging.
• Note: Patients who need anesthesia will be required to have 18F-MFBG imaging combined with other scans or procedures necessary for clinical care (ex: MRI, bone marrow aspirate/biopsies, line placement).
• Patients will be able to enroll prior to baseline 123I-MIBG imaging. However, patients who have had their baseline standard of care 123I-MIBG imaging prior to enrollment who have known MIBG non-avid disease are not eligible.
• Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible.

Sponsors & Collaborators

• Children's Oncology Group: lead

MeSH Terms

Conditions

Ganglioneuroblastoma

Interventions

Specimen Handling; 3-fluorobenzylguanidine; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neuroblastoma; 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

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Spectrum Analysis; Chemistry Techniques, Analytical

Study Officials

• Tanya C Watt

  Pediatric Early Phase Clinical Trial Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2025
• First Posted: March 5, 2025
• Study Start (Estimated): June 22, 2026
• Primary Completion (Estimated): December 20, 2028
• Study Completion (Estimated): December 20, 2028
• Last Updated: March 19, 2026

Record last verified: 2026-03