MR Perfusion Methods in Patients With Suspected Recurrent High Grade Gliomas

NCT02919865 | Completed

• 1 other identifier: 20160425-01H
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Radiation therapy is an important adjunct in the treatment of patients with glioma, although a common side effect is radiation-induced injury of brain parenchyma. Unfortunately, conventional MRI is not accurate in differentiating radiation-induced brain injury from recurrent tumour, both of which may demonstrate progressive contrast enhancement. Recent studies have suggested that perfusion MRI could improve this differentiation. Perfusion MRI can be performed with an injection of exogenous contrast using dynamic contrast enhancement (DCE) or dynamic susceptibility contrast enhancement (DSC). Perfusion MRI can also be performed without contrast injection using arterial spin labeling (ASL) or intravoxel incoherent motion (IVIM). DCE-MRI relies on accurate measurement of T1 values in order to convert the MRI signal intensity to contrast concentration. Dynamic susceptibility-weighted contrast enhancement (DSC) perfusion is the most common technique used in clinical practice but measurement of tumor relative cerebral blood volume (rCBV) can be biased by extravascular contrast leakage and susceptibility-weighted artifacts. The purpose of this study is to evaluate the accuracy of perfusion MR imaging using non-contrast and contrast-based techniques in differentiating recurrent tumour from radiation-induced brain injury in patients with known high grade glioma. The investigators will compare the accuracy of IVIM, ASL, DCE and DSC techniques. A secondary goal of the study is to compare two new different T1 mapping methods used for DCE-MRI.

Conditions

Glioma

Outcome Measures

Primary Outcomes (1)

• Estimate the Receiver Operating Characteristic (ROC) curve

  Estimate the Receiver Operating Characteristic (ROC) curve for the assessment of the diagnostic accuracy of f, CBF, CBV, Cp and Ktrans, obtained from different MR perfusion acquisition methods for distinguishing recurrent tumour from radiation necrosis.

  up to 22 months

Secondary Outcomes (1)

• Different T1 mapping methods used for DCE-MRI will be compared to the current gold standard

  up to 22 months

Study Arms (1)

MRI perfusion imaging

OTHER

Patients who have received chemoradiation for high grade gliomas and who subsequently developed progressive enhancing lesions on follow-up MR will be asked to participate in this study.

Device: MR perfusion imaging

Interventions

MR perfusion imaging DEVICE

MR perfusion imaging will be performed in addition to the routine neuronavigational sequence obtained from re-operative/therapy planning. Following MR examination, patient may undergo a surgical biopsy or excision as determined clinically by the neurosurgeon. All patients, including those who do not go to surgery, will undergo clinical follow-up and imaging follow-up with perfusion imaging. This will allow for assessment of lesion progression over time, yielding valuable diagnostic information in differentiating radiation necrosis from tumour recurrence, particularly in those patients who do not undergo surgery.

MRI perfusion imaging

Eligibility Criteria

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

You may qualify if:

• Patients enrolled must have:
• Had a diagnosis of high grade glioma and had received chemoradiation
• Developed a new lesion or an increase size of their treated lesion on follow-up MRI (either on post contrast T1W images or on FLAIR)
• Karnofsky performance status (kps) score \>70 (potential candidate for reresection of stereotactic radiation)

You may not qualify if:

• Patients under 18 years of age
• Pregnant patients (for women of child bearing potential - a negative serum beta HCGT is required).
• Known or suspected allergies to gadolinium-based contrast agents.
• Patients with chronic or acute renal insufficiency (glomerular filtration rate \< 30 mL/min/1.73m2), including acute renal insufficiency of any severity due to hepatorenal syndrome or in the perioperative liver transplantation period.
• General contraindications to MRI such as pacemaker or ferromagnetic implants.
• Severe cardiovascular disease
• Intractable seizures while on adequate anticonvulsant therapy (more than one seizure per month for the past 2 months)
• Sickle-cell anaemia or other known hemoglobinopathies, or other forms of haemolytic anaemia

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1Y1J7, Canada

Location

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2016
• First Posted: September 29, 2016
• Study Start: December 13, 2017
• Primary Completion: August 3, 2021
• Study Completion: August 3, 2021
• Last Updated: October 8, 2021

Record last verified: 2021-10

Locations

CA (1)