Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04724369 | Open-Label Study of 18F-mFBG for Imaging Neuroblastoma | PHASE3 | ACTIVE NOT_RECRUITING | 43 | — | — | Nov 18, 2021 | Aug 30, 2026 | Apr 3, 2026 | 8 | United States |
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
| Arm | Type | Description |
|---|---|---|
| Study Cohort: Subjects with known or presumed neuroblastoma | EXPERIMENTAL | Drug: 18F-mFBG Positron-emitting radiopharmaceutical 18F-mFBG as an imaging agent for identification of neuroblastoma. Other Names: * meta-fluorobenzylguanidine * IRP101 |
| Name | Type | Description |
|---|---|---|
| 18F-MFBG | DRUG | Positron-emitting tomography (PET) (either PET/CT or PET/MR) imaging agent |
Inclusion Criteria: 1. a) 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 ...