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

Launched by CHILDREN'S ONCOLOGY GROUP · Feb 27, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new type of imaging scan called 18F-MFBG to see if it can more accurately detect tumors in children and young adults with newly diagnosed, high-risk neuroblastoma compared to the standard imaging method, 123I-MIBG. Neuroblastoma is a type of cancer that affects nerve cells, and high-risk cases can be more challenging to treat. Participants in the trial will receive an injection of 18F-MFBG, which helps doctors see the tumors clearly using advanced imaging techniques like PET/CT or PET/MRI scans. These scans provide detailed pictures of the inside of the body, helping doctors understand where the tumors are located and how extensive the disease is.

To be eligible for this trial, patients must have been recently diagnosed with high-risk neuroblastoma or ganglioneuroblastoma, and they can be of any age. They should not have received certain medications that could interfere with the imaging results and must not be pregnant or breastfeeding. Participants can expect to have their imaging done before starting any treatment, and they may have additional tests and monitoring throughout the study. This trial is important because it could improve the way doctors identify and treat neuroblastoma, ultimately leading to better outcomes for patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • 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.