qBOLD MRI of Glioblastoma Multiforme for Assessment of Tumor Hypoxia.

NCT02466828 | Completed Early Phase 1 DMC

• 1 other identifier: 127-2014
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief Summary

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

Glioblastoma; Hypoxia

Outcome Measures

Primary Outcomes (1)

• Oxygen saturation in GBM with qBOLD MRI and its correlation with histological markers of tissue hypoxia and angiogenesis

  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.

  Within 8 hours after the MRI exam is complete

Secondary Outcomes (1)

• Oxygen saturation in GBM with qBOLD MRI and its correlation with targeted intraoperative oxygen measurement

  Within 8 hours after the MRI exam is complete

Study Arms (1)

Single patient group receiving Feraheme®

EXPERIMENTAL

Newly diagnosed GBM patients with no prior treatment will receive Feraheme® as MRI contrast agent

Drug: Feraheme®

Interventions

Feraheme® DRUG

Drug will be diluted in 50 cc normal saline and infused over 15-60 minutes depending on patient condition.

Also known as: ferumoxytol

Single patient group receiving Feraheme®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (\>18 year old) patients with newly diagnosed GBM presenting to our centre for surgical management and post-operative chemoradiation
• Creatinine clearance \> 60 ml/minute
• Able to tolerate an MR scan
• Capable of providing informed consent.

You may not qualify if:

• Prior brain surgery or radiation
• 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)
• On more than two antihypertensive medications
• History of allergy or adverse reaction to iron supplements
• Prior treatment with ferumoxytol
• Large (\>50%) hemorrhagic component in the solid enhancing part of the tumor
• Need for emergency craniotomy.
• Pregnant patients
• Breast feeding
• Serum ferritin of \>800 ng/mL

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• Unity Health Toronto: collaborator

Study Sites (2)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

MeSH Terms

Conditions

Glioblastoma; Hypoxia

Interventions

Ferrosoferric Oxide

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Ferrous Compounds; Minerals

Study Officials

• Pejman Jabehdar Maralani, MD FRCPC

  Sunnybrook Health Sciences Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2014
• First Posted: June 9, 2015
• Study Start: March 1, 2015
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: April 18, 2018

Record last verified: 2018-04

Locations

CA (2)