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18F-MFBG · 2 trials · 3 indications
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
All image data will be analyzed to develop and validate quantitative measures of global and regional myocardial uptake of 18F-mFBG at two times between injection and 60 minutes post-administration. The data from subjects without Lewy body disease will be used in comparisons with equivalent results for Lewy body disease subjects. Results for subjects imaged in this study will also be compared with historical data from imaging of healthy control subjects without heart disease.
| 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 |
| Cohort 1: Known or presumed Lewy body disease (Parkinson's disease (PD) and Lewy body dementia (LBD) | ACTIVE_COMPARATOR | All subjects will receive an intravenous injection of 222-370 MBq (6-10 mCi) 18F-mFBG. At 30 minutes post-administration, whole-body imaging will be performed from the head to the pelvis. A static image of the thorax will be acquired at 60 minutes. |
| Cohort 2: neurologic disease due to non-Lewy body pathology. | ACTIVE_COMPARATOR | All subjects will receive an intravenous injection of 222-370 MBq (6-10 mCi) 18F-mFBG. At 30 minutes post-administration, whole-body imaging will be performed from the head to the pelvis. A static image of the thorax will be acquired at 60 minutes. |
| 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 ...
18F-MFBG is an investigational small molecule imaging agent being studied for use in neuroblastoma and Parkinson Disease (PD). It is a radiotracer designed for positron emission tomography (PET) imaging. In neuroblastoma, it is being evaluated to detect tumors, and in Parkinson Disease, it is being studied for cardiac uptake related to Lewy body dementia.
18F-MFBG is being developed by Illumina, Inc., a company publicly traded under the ticker ILMN. Illumina is conducting clinical trials to evaluate the imaging agent for neuroblastoma and Parkinson Disease.
18F-MFBG is in Phase 3 clinical development for neuroblastoma, based on an active but not recruiting trial. It is also in Phase 2 for Parkinson Disease and Lewy body dementia, with a trial currently recruiting participants. The drug is investigational and not yet approved.
18F-MFBG is being studied in two clinical trials. NCT04724369 is a Phase 3 open-label study imaging neuroblastoma in the United States, with 43 participants, active but not recruiting. NCT07176286 is a Phase 2 study of cardiac uptake in Parkinson Disease and Lewy body dementia, recruiting 20 participants in the United States.
Yes, 18F-MFBG and 18F-mFBG refer to the same investigational imaging agent. The drug name appears in both formats across clinical trial records, with 18F-mFBG used in the titles of the neuroblastoma and cardiac uptake studies.