Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

MR Perfusion Methods in Patients With Suspected Recurrent High Grade Gliomas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02919865
Recruitment Status : Recruiting
First Posted : September 29, 2016
Last Update Posted : March 27, 2020
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 Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
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
Actual Study Start Date : December 13, 2017
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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


Contacts
Layout table for location contacts
Contact: Thanh Nguyen, MD 613-798-5555 ext 14982 thnguyen@toh.ca

Locations
Layout table for location information
Canada, Ontario
The Ottawa Hospital Recruiting
Ottawa, Ontario, Canada, K1Y1J7
Contact: Thanh Nguyen, MD    613-798-5555 ext 14982    thnguyen@toh.ca   
Contact: Betty Anne Schwarz, Phd    613-798-5555 ext 17522    baschwarz@toh.ca   
Sponsors and Collaborators
Ottawa Hospital Research Institute
Layout table for additonal information
Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT02919865    
Other Study ID Numbers: 20160425-01H
First Posted: September 29, 2016    Key Record Dates
Last Update Posted: March 27, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue