Trial Outcomes & Findings for MRI Study With Ferumoxytol in Assessing Early Response in Patients With Glioblastoma Multiforme Receiving Temozolomide and Radiation Therapy (NCT NCT00660543)

Results Overview

Radiographical progression is determined based on RANO criteria.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

14 participants

Primary outcome timeframe

At radiographical progression (between 6 and 12 weeks post first dose of chemoradiation)

Results posted on

2017-05-16

Participant Flow

Participant milestones

Participant milestones
Measure	Gadoteridol + Ferumoxytol Contrast Agent Subjects all received gadolinium enhanced MR on day 1, ferumoxytol enhanced MR on day 2, and delayed MR imaging on day 3 - this 3 day sequence of imaging was repeated at four time points.
Overall Study STARTED	14
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

MRI Study With Ferumoxytol in Assessing Early Response in Patients With Glioblastoma Multiforme Receiving Temozolomide and Radiation Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Gadoteridol + Ferumoxytol Contrast Agent n=14 Participants Subjects all received gadolinium enhanced MR on day 1, ferumoxytol enhanced MR on day 2, and delayed MR imaging on day 3 - this 3 day sequence of imaging was repeated at four time points.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants
Age, Continuous	60 years 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: At radiographical progression (between 6 and 12 weeks post first dose of chemoradiation)

Population: All patients with treated GMB showed apparent tumor progression on conventional MR images.

Radiographical progression is determined based on RANO criteria.

Outcome measures

Outcome measures
Measure	Ferumoxytol n=14 Participants Patients receive gadolinium IV on day 1 and ferumoxytol non-stoichiometric magnetite IV on day 2 then undergo DSC MRI, and DCE MRI, DWI (day 1 only), and TOF MR angiography on days 1-3 at 4 time points: before radiation, 3 weeks after initiation of radiation plus temozolomide, at the end of radiation (6 weeks post first dose) and 6 weeks after radiation (12 weeks post first dose).	Gadoteridol n=14 Participants Patients receive gadoteridol IV on day 1 then undergo DSC MRI, and DCE MRI, DWI (day 1 only), and TOF MR angiography on days 1-3 at 4 time points: before radiation, 3 weeks after initiation of radiation plus temozolomide, at the end of radiation (6 weeks post first dose) and 6 weeks after radiation (12 weeks post first dose).	Gadoteridol Leakage Correction n=14 Participants Patients receive gadoteridol IV on day 1 then undergo DSC MRI, and DCE MRI, DWI (day 1 only), and TOF MR angiography on days 1-3 at 4 time points: before radiation, 3 weeks after initiation of radiation plus temozolomide, at the end of radiation (6 weeks post first dose) and 6 weeks after radiation (12 weeks post first dose).
Mean Cerebral Blood Volume (CBV)	2.5 mL/g Standard Deviation 2.1	1.38 mL/g Standard Deviation 1.73	2.36 mL/g Standard Deviation 1.94

PRIMARY outcome

Timeframe: Anytime between baseline and 12 weeks post treatment initiation: average 6 weeks post treatment initiation.

Tumor progression was assessed by RANO criteria (Wen, 2010).

Outcome measures

Outcome measures
Measure	Ferumoxytol n=14 Participants Patients receive gadolinium IV on day 1 and ferumoxytol non-stoichiometric magnetite IV on day 2 then undergo DSC MRI, and DCE MRI, DWI (day 1 only), and TOF MR angiography on days 1-3 at 4 time points: before radiation, 3 weeks after initiation of radiation plus temozolomide, at the end of radiation (6 weeks post first dose) and 6 weeks after radiation (12 weeks post first dose).	Gadoteridol Patients receive gadoteridol IV on day 1 then undergo DSC MRI, and DCE MRI, DWI (day 1 only), and TOF MR angiography on days 1-3 at 4 time points: before radiation, 3 weeks after initiation of radiation plus temozolomide, at the end of radiation (6 weeks post first dose) and 6 weeks after radiation (12 weeks post first dose).	Gadoteridol Leakage Correction Patients receive gadoteridol IV on day 1 then undergo DSC MRI, and DCE MRI, DWI (day 1 only), and TOF MR angiography on days 1-3 at 4 time points: before radiation, 3 weeks after initiation of radiation plus temozolomide, at the end of radiation (6 weeks post first dose) and 6 weeks after radiation (12 weeks post first dose).
Tumor Progression on Conventional MR	14 participants	—	—

Adverse Events

Ferumoxytol

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Gadoteridol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Gadoteridol With Leakage Correction

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Ferumoxytol n=14 participants at risk Subjects all received ferumoxytol enhanced MR on day 1, ferumoxytol enhanced MR on day 2, and delayed MR imaging on day 3 - this 3 day sequence of imaging was repeated at four time points	Gadoteridol n=14 participants at risk Subjects all received gadolinium enhanced MR on day 1, ferumoxytol enhanced MR on day 2, and delayed MR imaging on day 3 - this 3 day sequence of imaging was repeated at four time points	Gadoteridol With Leakage Correction n=14 participants at risk Subjects all received gadolinium enhanced MR on day 1, ferumoxytol enhanced MR on day 2, and delayed MR imaging on day 3 - this 3 day sequence of imaging was repeated at four time points
Gastrointestinal disorders Nausea	7.1% 1/14 • Number of events 1	0.00% 0/14	0.00% 0/14

Additional Information

Dr. Edward Neuwelt

Oregon Health and Science University

Phone: 503-494-5626

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place