Trial Outcomes & Findings for DSC-MRI With Ferumoxytol and DCE-MRI With Gadolinium in Imaging Vascular Properties in Younger Patients With Brain Tumors (NCT NCT00978562)

Last Updated: 2022-08-03

Results Overview

Signal intensity, relative cerebral blood volume (rCBV) was measured. Relative CBV measurements were calculated from regions of interest (ROI) that were placed in regions of highest perfusion seen on the rCBV color overlay parametric maps.The mean of 3 regions of contralateral white matter was used as the internal reference standard. The size of the ROIs was kept constant (radius 1.5 mm). Parametric color overlay maps were analyzed using ImageJ software (NIH, Bethesda, MD, USA).

Recruitment status

COMPLETED

Study phase

EARLY_PHASE1

Target enrollment

14 participants

Primary outcome timeframe

Up to 2 years

Results posted on

2022-08-03

Participant Flow

Participant milestones

Participant milestones
Measure	Diagnostic (DSC-MRI With Ferumoxytol, DCE-MRI With Gadolinium) Patients receive ferumoxytol and gadolinium IV and then undergo DSC-MRI and DCE-MRI. An optional MRI without injection of a contrast agent may be obtained after 20-24 hours at the discretion of the clinician. Patients may receive up to 3 more scans at least 3 weeks apart over up to 2 years. Dynamic Contrast-Enhanced Magnetic Resonance Imaging: Undergo DCE-MRI Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging: Undergo DSC-MRI Ferumoxytol Non-Stoichiometric Magnetite: Given IV Gadolinium: Given IV
Overall Study STARTED	14
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Diagnostic (DSC-MRI With Ferumoxytol, DCE-MRI With Gadolinium) Patients receive ferumoxytol and gadolinium IV and then undergo DSC-MRI and DCE-MRI. An optional MRI without injection of a contrast agent may be obtained after 20-24 hours at the discretion of the clinician. Patients may receive up to 3 more scans at least 3 weeks apart over up to 2 years. Dynamic Contrast-Enhanced Magnetic Resonance Imaging: Undergo DCE-MRI Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging: Undergo DSC-MRI Ferumoxytol Non-Stoichiometric Magnetite: Given IV Gadolinium: Given IV
Overall Study Withdrawal by participant before receiving study drug/imaging	2

Baseline Characteristics

DSC-MRI With Ferumoxytol and DCE-MRI With Gadolinium in Imaging Vascular Properties in Younger Patients With Brain Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Diagnostic (DSC-MRI With Ferumoxytol, DCE-MRI With Gadolinium) n=14 Participants Patients receive ferumoxytol and gadolinium IV and then undergo DSC-MRI and DCE-MRI. An optional MRI without injection of a contrast agent may be obtained after 20-24 hours at the discretion of the clinician. Patients may receive up to 3 more scans at least 3 weeks apart over up to 2 years. Dynamic Contrast-Enhanced Magnetic Resonance Imaging: Undergo DCE-MRI Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging: Undergo DSC-MRI Ferumoxytol Non-Stoichiometric Magnetite: Given IV Gadolinium: Given IV
Age, Continuous	10.64 years STANDARD_DEVIATION 3.33 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 2 years

Population: 7 participants had both appropriate ferumoxytol and gadolinium scans available for analysis for this outcome.

Outcome measures

Outcome measures
Measure	Diagnostic (DSC-MRI With Ferumoxytol, DCE-MRI With Gadolinium) n=7 Participants Patients receive ferumoxytol and gadolinium IV and then undergo DSC-MRI and DCE-MRI. An optional MRI without injection of a contrast agent may be obtained after 20-24 hours at the discretion of the clinician. Patients may receive up to 3 more scans at least 3 weeks apart over up to 2 years. Dynamic Contrast-Enhanced Magnetic Resonance Imaging: Undergo DCE-MRI Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging: Undergo DSC-MRI Ferumoxytol Non-Stoichiometric Magnetite: Given IV Gadolinium: Given IV
Vascular Properties of Pediatric Brain Tumors Using Dynamic Susceptibility-weighted Contrast Enhanced MRI (DSC-MRI) After Administration of Ferumoxytol	.93 mL/g Standard Deviation 1.44

PRIMARY outcome

Timeframe: up to 2 years

Population: 7 participants had both appropriate ferumoxytol and gadolinium scans available for analysis for this outcome.

Volume transfer coefficient reflecting vascular permeability of pediatric brain tumors using Dynamic Contrast-enhanced MRI (DCE-MRI) was measured. Subjects undergo MRI with ferumoxytol (study drug) and gadolinium (standard contrast agent) in the same imaging session. Ferumoxytol is given first and DSC images obtained, followed by gadolinium, and DCE images are obtained.

Outcome measures

Outcome measures
Measure	Diagnostic (DSC-MRI With Ferumoxytol, DCE-MRI With Gadolinium) n=7 Participants Patients receive ferumoxytol and gadolinium IV and then undergo DSC-MRI and DCE-MRI. An optional MRI without injection of a contrast agent may be obtained after 20-24 hours at the discretion of the clinician. Patients may receive up to 3 more scans at least 3 weeks apart over up to 2 years. Dynamic Contrast-Enhanced Magnetic Resonance Imaging: Undergo DCE-MRI Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging: Undergo DSC-MRI Ferumoxytol Non-Stoichiometric Magnetite: Given IV Gadolinium: Given IV
Vascular Properties of Pediatric Brain Tumors Using Dynamic Contrast-enhanced MRI (DCE-MRI) After Administration of a Gadolinium-based Contrast Agent	.25 min^-1 Standard Deviation .23

Adverse Events

Diagnostic (DSC-MRI With Ferumoxytol, DCE-MRI With Gadolinium)

Serious events: 2 serious events

Other events: 8 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Diagnostic (DSC-MRI With Ferumoxytol, DCE-MRI With Gadolinium) n=14 participants at risk Patients receive ferumoxytol and gadolinium IV and then undergo DSC-MRI and DCE-MRI. An optional MRI without injection of a contrast agent may be obtained after 20-24 hours at the discretion of the clinician. Patients may receive up to 3 more scans at least 3 weeks apart over up to 2 years. Dynamic Contrast-Enhanced Magnetic Resonance Imaging: Undergo DCE-MRI Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging: Undergo DSC-MRI Ferumoxytol Non-Stoichiometric Magnetite: Given IV Gadolinium: Given IV
Nervous system disorders Shunt malfunction and revision	7.1% 1/14 • Number of events 1 • Assessed up to 2 years All grades of adverse events were collected using Common Terminology Criteria for Adverse Events\_v3.0 (CTCAE) (http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm)
General disorders Death	7.1% 1/14 • Number of events 1 • Assessed up to 2 years All grades of adverse events were collected using Common Terminology Criteria for Adverse Events\_v3.0 (CTCAE) (http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm)

Other adverse events

Other adverse events
Measure	Diagnostic (DSC-MRI With Ferumoxytol, DCE-MRI With Gadolinium) n=14 participants at risk Patients receive ferumoxytol and gadolinium IV and then undergo DSC-MRI and DCE-MRI. An optional MRI without injection of a contrast agent may be obtained after 20-24 hours at the discretion of the clinician. Patients may receive up to 3 more scans at least 3 weeks apart over up to 2 years. Dynamic Contrast-Enhanced Magnetic Resonance Imaging: Undergo DCE-MRI Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging: Undergo DSC-MRI Ferumoxytol Non-Stoichiometric Magnetite: Given IV Gadolinium: Given IV
Gastrointestinal disorders Nausea	21.4% 3/14 • Number of events 3 • Assessed up to 2 years All grades of adverse events were collected using Common Terminology Criteria for Adverse Events\_v3.0 (CTCAE) (http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm)
Gastrointestinal disorders Vomiting	14.3% 2/14 • Number of events 2 • Assessed up to 2 years All grades of adverse events were collected using Common Terminology Criteria for Adverse Events\_v3.0 (CTCAE) (http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm)
Nervous system disorders Diplopia	7.1% 1/14 • Number of events 1 • Assessed up to 2 years All grades of adverse events were collected using Common Terminology Criteria for Adverse Events\_v3.0 (CTCAE) (http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm)
Nervous system disorders Nystagmus	7.1% 1/14 • Number of events 1 • Assessed up to 2 years All grades of adverse events were collected using Common Terminology Criteria for Adverse Events\_v3.0 (CTCAE) (http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm)
Nervous system disorders seizure	7.1% 1/14 • Number of events 1 • Assessed up to 2 years All grades of adverse events were collected using Common Terminology Criteria for Adverse Events\_v3.0 (CTCAE) (http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm)
Nervous system disorders headache	7.1% 1/14 • Number of events 1 • Assessed up to 2 years All grades of adverse events were collected using Common Terminology Criteria for Adverse Events\_v3.0 (CTCAE) (http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm)
Skin and subcutaneous tissue disorders Dry skin	7.1% 1/14 • Number of events 1 • Assessed up to 2 years All grades of adverse events were collected using Common Terminology Criteria for Adverse Events\_v3.0 (CTCAE) (http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm)
Skin and subcutaneous tissue disorders teleangiectasia	7.1% 1/14 • Number of events 1 • Assessed up to 2 years All grades of adverse events were collected using Common Terminology Criteria for Adverse Events\_v3.0 (CTCAE) (http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm)
Gastrointestinal disorders Diarrhea	7.1% 1/14 • Number of events 1 • Assessed up to 2 years All grades of adverse events were collected using Common Terminology Criteria for Adverse Events\_v3.0 (CTCAE) (http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm)
General disorders Fever	7.1% 1/14 • Number of events 1 • Assessed up to 2 years All grades of adverse events were collected using Common Terminology Criteria for Adverse Events\_v3.0 (CTCAE) (http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm)
Gastrointestinal disorders Constipation	7.1% 1/14 • Number of events 1 • Assessed up to 2 years All grades of adverse events were collected using Common Terminology Criteria for Adverse Events\_v3.0 (CTCAE) (http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm)
Infections and infestations Viral infection	7.1% 1/14 • Number of events 1 • Assessed up to 2 years All grades of adverse events were collected using Common Terminology Criteria for Adverse Events\_v3.0 (CTCAE) (http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm)
General disorders Fatigue	7.1% 1/14 • Number of events 1 • Assessed up to 2 years All grades of adverse events were collected using Common Terminology Criteria for Adverse Events\_v3.0 (CTCAE) (http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm)
General disorders Body aches	7.1% 1/14 • Number of events 1 • Assessed up to 2 years All grades of adverse events were collected using Common Terminology Criteria for Adverse Events\_v3.0 (CTCAE) (http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm)
Infections and infestations Shunt infection	7.1% 1/14 • Number of events 1 • Assessed up to 2 years All grades of adverse events were collected using Common Terminology Criteria for Adverse Events\_v3.0 (CTCAE) (http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm)

Additional Information

Edward Neuwelt, MD

OHSU KCI

Phone: 503-494-5626

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place