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MR Perfusion Methods in Patients With Suspected Recurrent High Grade Gliomas

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ClinicalTrials.gov Identifier: NCT02919865
Recruitment Status : Not yet recruiting
First Posted : September 29, 2016
Last Update Posted : February 2, 2017
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

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.

Condition or disease Intervention/treatment Phase
Glioma Device: MR perfusion imaging Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Accuracy of MR Perfusion Without and With Gadolinium at 3T in the Diagnosis of Patients With Suspected Recurrent High Grade Gliomas
Estimated Study Start Date : February 2017
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
MRI perfusion imaging
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

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.





Primary Outcome Measures :
  1. Estimate the Receiver Operating Characteristic (ROC) curve [ Time Frame: up to 22 months ]
    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.


Secondary Outcome Measures :
  1. Different T1 mapping methods used for DCE-MRI will be compared to the current gold standard [ Time Frame: up to 22 months ]
    Different T1 mapping methods used for DCE-MRI (MOLLI that measures apparent T1 and SMARTMap that measures true T1) will be compared to the current gold standard (inversion recovery).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients enrolled must have:

  1. Had a diagnosis of high grade glioma and had received chemoradiation
  2. 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)
  3. Karnofsky performance status (kps) score >70 (potential candidate for reresection of stereotactic radiation)

Exclusion Criteria:

  1. Patients under 18 years of age
  2. Pregnant patients (for women of child bearing potential - a negative serum beta HCGT is required).
  3. Known or suspected allergies to gadolinium-based contrast agents.
  4. 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.
  5. General contraindications to MRI such as pacemaker or ferromagnetic implants.
  6. Severe cardiovascular disease
  7. Intractable seizures while on adequate anticonvulsant therapy (more than one seizure per month for the past 2 months)
  8. Sickle-cell anaemia or other known hemoglobinopathies, or other forms of haemolytic anaemia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02919865


Locations
Canada, Ontario
The Ottawa Hospital
Ottawa, Ontario, Canada, K1Y1J7
Sponsors and Collaborators
Ottawa Hospital Research Institute

Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT02919865     History of Changes
Other Study ID Numbers: 20160425-01H
First Posted: September 29, 2016    Key Record Dates
Last Update Posted: February 2, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Additional relevant MeSH terms:
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue