Clinical trial · Interventional
qBOLD MRI of Glioblastoma Multiforme for Assessment of Tumor Hypoxia.
Quantitative Blood Oxygenation Level Dependent (qBOLD) MR Imaging of Glioblastoma Multiforme for Assessment of Tumor Hypoxia.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Glioblastoma multiforme (GBM) is the most common primary malignant brain neoplasm in adults. Despite recent diagnostic and therapeutic advances, including aggressive surgical resection and chemoradiation, the prognosis of GBM has improved only slightly over the past two decades, with median survival of approximately 15 months. Tumor hypoxia is a feature of GBM that contributes to poor outcome through multiple mechanisms such as 1) overexpression of enzymes that play roles in temozolomide resistance, the main chemotherapeutic agent in GBM and 2) increase expression of cancer stem cells which are more resistant to radiation. Hypoxic tumour regions are associated with higher rates of progression and recurrence. In this study the investigators will use an advanced MRI technique called qBOLD to non-invasively measure oxygenation in GBM and obtain targeted biopsies. The investigators take advantage of physical characteristics of Ferumoxytol (Feraheme®) which is an iron supplement, and utilize two recent technical advances not previously used in human tumours to quantitatively measure oxygenation in GBM. Prior knowledge of hypoxia can assist in prognostication and individualization of treatment planning with special focus on hypoxic regions by targeted radiation dose or regimen modulation; consideration of more intensive chemotherapy regimens; more aggressive and targeted surgical resection and closer short-term clinical and imaging follow-ups.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
| Hypoxia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Feraheme® | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single patient group receiving Feraheme®
- description
- Newly diagnosed GBM patients with no prior treatment will receive Feraheme® as MRI contrast agent
- interventionNames
- Drug: Feraheme®
Primary outcomes (1)
- measure
- Oxygen saturation in GBM with qBOLD MRI and its correlation with histological markers of tissue hypoxia and angiogenesis
- timeFrame
- Within 8 hours after the MRI exam is complete
- description
- Pre-operative qBOLD imaging and O2 saturation mapping will be performed in 27 newly diagnosed GBM patients and targeted biopsies will be obtained from the hypoxic and non-hypoxic regions of the tumor.
Secondary outcomes (1)
- measure
- Oxygen saturation in GBM with qBOLD MRI and its correlation with targeted intraoperative oxygen measurement
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Adult (\>18 year old) patients with newly diagnosed GBM presenting to our centre for surgical management and post-operative chemoradiation 2. Creatinine clearance \> 60 ml/minute 3. Able to tolerate an MR scan 4. Capable of providing informed consent. Exclusion Criteria: 1. Prior brain surgery or radiation 2. History of liver disease requiring liver MRI (due to accumulation of ferumoxytol in Kupffer cells which can affect liver MRI for up to 3 months) 3. On more than two antihypertensive medications 4. History of allergy or adverse reaction to iron supplements 5. Prior treatment with ferumoxytol 6. Large (\>50%) hemorrhagic component in the solid enhancing part of the tumor 7. Need for emergency craniotomy. 8. Pregnant patients 9. Breast feeding 10. Serum ferritin of \>800 ng/mL
References
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