Open-Label Study of 18F-mFBG for Imaging Neuroblastoma
Study Details
Study Description
Brief Summary
This is a Phase 3 study evaluating the positron-emitting radiopharmaceutical 18F-mFBG as an imaging agent for confirming or excluding the presence of neuroblastoma
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Detailed Description
This is a prospective, Phase 3, multi-center, open-label study designed to assess the use of 18F-mFBG PET imaging in subjects with known or presumed neuroblastoma. Eligible participants will have either histopathologically established diagnosis of neuroblastoma or a presumed diagnosis based on signs, symptoms, physical examination, imaging findings, and laboratory and genetic test results.
Subjects will only be administered 18F-mFBG if they have undergone or are scheduled to undergo a 123I-mIBG or 18F-FDG scan within 30 days of the date of the 18F-mFBG scan. Subjects should not have received any chemotherapy, immunotherapy or radiotherapy between the clinical and 18F-mFBG imaging studies.
18F-mFBG PET studies and clinical 123I-mIBG scans will be evaluated off-site by 3 independent radiologists and/or nuclear medicine physicians who are blinded to all subject information. Blinded readers will record whether findings on 18F-mFBG and 123I-mIBG scans are consistent with presence of neuroblastoma (Disease +) or absence of disease (Disease -).
Subject-level diagnostic performance will be assessed on the basis of positive and negative percent agreement (PPA and NPA) between the blinded 18F-mFBG scan interpretations and disease status (+ or - for neuroblastoma) as independently assessed by an Expert Panel of pediatric oncologists.
Secondary efficacy analyses will compare PPA and NPA between 18F-mFBG and 123I-mIBG interpretations provided by the blinded readers.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Study Cohort: Subjects with known or presumed neuroblastoma Drug: 18F-mFBG Positron-emitting radiopharmaceutical 18F-mFBG as an imaging agent for identification of neuroblastoma. Other Names: meta-fluorobenzylguanidine IRP101 |
Drug: 18F-MFBG
Positron-emitting tomography (PET) (either PET/CT or PET/MR) imaging agent
Other Names:
|
Outcome Measures
Primary Outcome Measures
- PET Scan Identification of Neuroblastoma [Imaging at 60 minutes]
Focal 18F-mFBG uptake (presence or absence) when imaging at 60 minutes with PET/CT or PET/MR, reported as positive and negative predictive agreement with expert oncologist assessment for presence of neuroblastoma
Secondary Outcome Measures
- Comparison of 18F-mFBG PET With Clinical 123I-mIBG Imaging [Scan interpretation up to one month after intervention.]
This objective will be assessed using the secondary endpoint of focal increased 123I-mIBG uptake (presence or absence), reported as positive and negative predictive agreement with expert oncologist assessment for presence of neuroblastoma
- Number of subjects with adverse events graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5. [24 hours following 18F-mFBG administration.]
Description: Assessments based on changes between pre- and post-18F-mFBG administration physical examination findings, vital signs measurements, blood test results including hematology and biochemistry, and electrocardiograms (ECGs).
Eligibility Criteria
Criteria
Inclusion Criteria:
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- 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.
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The subject has undergone or is scheduled to undergo evaluation of neuroblastoma disease status, including at least one functional imaging study (123I-mIBG or 18F-FDG), within 30 days prior to the date of 18F-mFBG imaging, with no interval therapy between such evaluation and investigational drug administration.
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Ability of subject or subject's legal guardian to understand and sign a written informed consent document, including, for subjects age 7-17, an assent form.
Exclusion Criteria:
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The subject was previously entered into this study.
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The subject is pregnant, breast feeding, or menarchal and unwilling to use effective contraception during the study.
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The subject has a history or suspicion of significant allergic reaction or anaphylaxis to any components of the 18F-mFBG imaging agent.
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The subject is unable to lie flat or remain still for approximately 30 minutes to allow performance of a PET scan.
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The subject uses medications that are known to interfere with uptake of NET-dependent agents and these medications cannot be safely withheld 24 hours before study procedures.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Children's Hospital Los Angeles | Los Angeles | California | United States | 90027 |
| 2 | University of California, San Francisco | San Francisco | California | United States | 94143 |
| 3 | Riley Hospital for Children - Indiana University | Indianapolis | Indiana | United States | 46202 |
| 4 | Dana-Farber Cancer Institute | Boston | Massachusetts | United States | 02215 |
| 5 | University of Michigan Health System | Ann Arbor | Michigan | United States | 48109 |
| 6 | Memorial Sloan Kettering Cancer Center | New York | New York | United States | 10065 |
| 7 | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | United States | 45229 |
| 8 | The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | United States | 19104 |
Sponsors and Collaborators
- Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC)
- New Approaches to Neuroblastoma Therapy Consortium
- Memorial Sloan Kettering Cancer Center
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRP101-301