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CBF and NCF Changes With Brain Radiation

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: NCT03606421
Recruitment Status : Recruiting
First Posted : July 30, 2018
Last Update Posted : November 27, 2019
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Brief Summary:

This study will be a dual-arm prospective longitudinal cohort study for patients with brain metastases, at least one of which is appropriate for radiotherapy, to explore brain and cognitive changes following SRS or WBRT and evaluate the feasibility of a novel MRI protocol to identify potential radiological biomarkers of NCF decline.

Patients diagnosed with brain mets will be assigned to either Arm A or Arm B, depending on their treatment plan. Patients in Arm A will be treated with SRS. Patients in Arm B will be treated with WBRT.

Patients' neurocognitive function will be assessed before their radiation treatment and followed up for 2 years post treatment.


Condition or disease Intervention/treatment
Neurocognitive Dysfunction Brain Metastases Radiation: SRS and neurocognitive assessments Radiation: WBRT and neurocognitive assessments

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Study Type : Observational
Estimated Enrollment : 110 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Use of Novel MRI Techniques Before and After Brain Radiotherapy With Parallel Assessments of Neurocognitive Function
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : June 30, 2023

Group/Cohort Intervention/treatment
Arm A
Patients in Arm A will be treated with stereotactic radiosurgery (SRS) which is a modern method of treating brain lesions that delivers a high amount of radiation to a small volume of the brain affected by a tumour; and is the standard of care for patients with a limited number of brain metastases.
Radiation: SRS and neurocognitive assessments
Patients will be assessed for cerebral blood flow and their neurocognitive function based on a series of neurocognitive tests and questionnaires.

Arm B.
Patients in Arm B will be treated with whole brain radiotherapy, due to the number of lesions in their brain.
Radiation: WBRT and neurocognitive assessments
Patients will be assessed for cerebral blood flow and their neurocognitive function based on a series of neurocognitive tests and questionnaires.




Primary Outcome Measures :
  1. change in neurocognitive function (NCF) [ Time Frame: Over 24 months ]
    To characterize change in NCF from baseline (pre-SRS treatment), to 24 months following using the NCF-A Battery


Secondary Outcome Measures :
  1. Symptomatic Radiation Toxicity [ Time Frame: 3-24 months ]
    A diagnosis of symptomatic radiation toxicity will be based on a clinical onset of symptoms and radiological findings of radionecrosis at 3-24 months following radiosurgery, with or without pathological confirmation

  2. Local Failure [ Time Frame: up to 24 months ]
    Local failure will be defined as one of the following (follow-up MRI or CT brain scans will be compared to the prior MRI or CT brain scan): Increase of > 25% in the size of any lesion or a new, non- contiguous lesion developed outside the radiosurgical bed (in the brain or meninges). Radionecrosis will not be considered tumor progression.

  3. Distant Failure [ Time Frame: up to 24 months ]
    Distant disease is considered to be new metastatic lesions in the brain or outside the brain following WBRT and SRS.

  4. Survival [ Time Frame: up to 24 months ]
    Survival time will be measured from the date the patient is enrolled in this study to death, due to any cause



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with brain metastases, at least one of which is appropriate for radiotherapy
Criteria

Inclusion Criteria:

  • Patients with brain metastases will be included in this study. Patients with known malignancies but without brain metastases, or patients with primary brain tumors are not eligible for enrollment.
  • MRI confirmed 1-10 lesions. Each lesion must not be intended for resection.
  • No prior radiation therapy for brain tumours.
  • For patients enrolled to arm B, ability to tolerate RespirAct. Based on studies in patients with severe cerebrovascular disease, an 8 - 16% drop-out rate at the time of the first exposure to RespirAct CVR testing is expected [9]. The fourth generation of this device has been associated with increased tolerability secondary to elimination of a physical rebreathing circuit replaced by a digital re-breath analog. This improvement is expected to achieve a drop-out rate significantly below 10%.
  • Patients must have a GPA greater than or equal to 1.0.
  • Patients must be able to provide informed consent. Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate.
  • Patients must have sufficient fluency in English and sufficient motor and visual functioning (corrected or assisted as required) to complete the NCF-A battery.
  • Patients must be accessible for treatment, AE assessment and follow- up.
  • Limit to KPS ≥ 70 for patients in arm B; no limit for arm A
  • Women/men of childbearing potential must have agreed to use a highly effective contraceptive. Women of childbearing potential will have a pregnancy test to determine eligibility.

Exclusion Criteria:

  • Treatment plan respecting normal tissue tolerances using dose fractionation specified within the protocol cannot be achieved.
  • Pregnant patients will be excluded from this study.
  • Prior cranial radiotherapy
  • Inability to complete MRI with contrast of the head, or a known allergy to gadolinium
  • Metastatic germ cell tumor, small cell carcinoma, or lymphoma or any primary brain tumor.
  • Patients with known malignancies but without brain metastases.
  • Image Findings

    • Widespread definitive leptomeningeal metastasis
    • A brain metastasis that is located ≤ 2 mm of the optic chiasm
    • Evidence of midline shift
    • Fourth ventricular narrowing, concerning for hydrocephalus
  • Patients who have undergone surgical resection of brain tumor are not eligible for enrollment.

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): NCT03606421


Contacts
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Contact: David Shultz, MD 416-946-4501 ext 2127 david.shultz@rmp.uhn.ca

Locations
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Canada, Ontario
University Health Network Recruiting
Toronto, Ontario, Canada, L4W4C2
Contact: David Shultz, MD         
Sponsors and Collaborators
University Health Network, Toronto

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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03606421    
Other Study ID Numbers: 18-5106
First Posted: July 30, 2018    Key Record Dates
Last Update Posted: November 27, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders