Ferumoxytol MRI in Assessing Response to Pembrolizumab in Patients With Glioblastoma

Conditions

• Glioblastoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Ferumoxytol — DRUG
  Given IV
• Laboratory Biomarker Analysis — OTHER
  Correlative studies
• Magnetic Resonance Imaging — PROCEDURE
  Undergo ferumoxytol MRI
• Pembrolizumab — BIOLOGICAL
  Given IV

Study Details

This pilot phase II trial studies how well ferumoxytol magnetic resonance imaging (MRI) works in assessing response to pembrolizumab in patients with glioblastoma. Diagnostic procedures, such as ferumoxytol MRI, may help measure a patient's response to pembrolizumab treatment.

Key Dates

Start date

Dec 20, 2017

Status verified

Sep 2025

Primary completion

Dec 31, 2023

Completion

Jun 23, 2025

Study Design

Enrollment

52 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Diagnostic (Ferumoxytol MRI, pembrolizumab)
  Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 2 years or 35 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive ferumoxytol IV and undergo MRI scans at baseline, 4 weeks after the last day of standard of care stereotactic radiosurgery or chemoradiotherapy, every 9 weeks thereafter until suspected radiographic progression, and then within 4 weeks from suspected radiographic progression.

Primary Outcome Measure

Specificity of Identifying Pseudoprogression [ Time Frame: At suspected progression, up to two years. ]

Locations (1)

Related coverage on Hipa.ai

• Pembrolizumab: Ferumoxytol MRI shows 58.3% specificity for glioblastoma response
  Pembrolizumab · Sep 9, 2025 · ClinicalTrials.gov

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