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

ConditionsGanglioneuroblastoma Ganglioneuroblastoma, Nodular High Risk Neuroblastoma

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

AgeNot listed

SponsorChildren's Oncology Group

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

Biospecimen Collection
Procedure/Surgery
Undergo blood sample collection
Computed Tomography
Procedure/Surgery
Undergo PET/CT
Florbenguane F18
Radiation
Given IV
Magnetic Resonance Imaging
Procedure/Surgery
Undergo PET/MRI
Positron Emission Tomography
Procedure/Surgery
Undergo PET/CT or PET/MRI
Questionnaire Administration
Other intervention
Ancillary studies

Treatment groups

84 Participants

are divided into 1 treatment group

Group A: Diagnostic (18F-MFBG)Experimental treatment 6 interventions

Trial outcomes

Primary outcomes

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.

Time frame

Up to 105 days

Secondary outcomes

Individual metastatic lesion response

Will be assessed using iobenguane I-123 (123I-MIBG) and florbenguane F18 (18F-MFBG) imaging. Response will be summarized by number (percent \[%\]) of lesions stratified by imaging modality. A generalized linear mixed model will also estimate percent response by imaging modalities and compare response between modalities. The model will include fixed effects for modality, cumulative logit link function, multinomial distribution, and random effects for patient and lesion within patient.

Time frame

Up to 105 days

Curie scores

Will estimate the correlation between Curie scores on both 123I-MIBG and 18F-MFBG imaging using Spearman rank correlation with a 95% CI.

Time frame

Up to 3 years

Concordance in end of induction response

Will be measured as poor versus good. Will be assessed by 123I-MIBG and 18F-MFBG in patients receiving high-risk therapy. Will be estimated by the kappa coefficient.

Time frame

Up to 105 days

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

Will be assessed by primary (soft tissue) tumor response and tumor response at metastatic soft tissue and bone sites, in patients receiving high-risk therapy. Concordance will be estimated using Cohen's kappa.

Time frame

Up to 105 days

Other outcomes

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

Will be assessed by 123I-MIBG and 18F-MFBG. Will be estimated by the unweighted kappa coefficient and Cicchetti-Allison weight kappa coefficient with 95% confidence intervals.

Time frame

Up to 3 years

Natural history of discordant lesions

Will be assessed only by 18F-MFBG and not by 123I-MIBG in patients with high-risk neuroblastoma. The natural history of disease sites detected by 18F-MFBG and 123I-MIBG at diagnosis and during therapy will be evaluated in a patterns of failure analysis. Specific disease sites detected at relapse will be coded as having been identified by 18F-MFBG, 123I-MIBG, neither scan or both scans at diagnosis and at end of induction. The number of individual sites identified at relapse that were detected previously by 18F-MFBG, 123I-MIBG, neither or both scans will be tabulated and the proportion of sites detected by each scan type will be reported.

Time frame

Up to 3 years

Additional interventions undertaken based on identification of discordant lesions

Frequency of additional interventions undertaken based on identification of discordant lesions including additional imaging, biopsies, and additional therapies.

Time frame

Up to 3 years

Change in standardized uptake value (SUV) of the primary and metastatic lesions

Will be estimated using a general linear mixed model. The model will include fixed effects for lesion type (primary/metastatic), imaging modality, and the lesion type-imaging interaction term. The model will also include random effects for patient and lesion within patient. Contrasts will be specified to estimate the mean change in SUV between primary and metastatic lesions by imaging modality.

Time frame

Up to 105 days

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Children's Oncology Group

Lead sponsor

Source ClinicalTrials.gov

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