Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03606421
Other study ID # 18-5106
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 1, 2018
Est. completion date June 30, 2026

Study information

Verified date June 2024
Source University Health Network, Toronto
Contact David Shultz, MD
Phone 416-946-4501
Email david.shultz@rmp.uhn.ca
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 110
Est. completion date June 30, 2026
Est. primary completion date June 30, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

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.
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.

Locations

Country Name City State
Canada University Health Network Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary change in neurocognitive function (NCF) To characterize change in NCF from baseline (pre-SRS treatment), to 24 months following using the NCF-A Battery Over 24 months
Secondary Symptomatic Radiation Toxicity 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 3-24 months
Secondary Local Failure 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. up to 24 months
Secondary Distant Failure Distant disease is considered to be new metastatic lesions in the brain or outside the brain following WBRT and SRS. up to 24 months
Secondary Survival Survival time will be measured from the date the patient is enrolled in this study to death, due to any cause up to 24 months
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04074096 - Binimetinib Encorafenib Pembrolizumab +/- Stereotactic Radiosurgery in BRAFV600 Melanoma With Brain Metastasis Phase 2
Recruiting NCT04474925 - Pre- Versus Post-operative SRS for Resectable Brain Metastases Phase 3
Recruiting NCT05358340 - Dual Perfusion Imaging for Characterizing Vascular Architecture of Brain Lesions N/A
Recruiting NCT05559853 - Developing a New MRI Technique to Understand Changes in Brain Tumors After Treatment
Completed NCT03189381 - Pilot Phase 2 Study Whole Brain Radiation Therapy With Simultaneous Integrated Boost for Patients With Brain Metastases N/A
Completed NCT02082587 - Toronto BNB Pilot Study N/A
Terminated NCT01551680 - A Trial Evaluating Concurrent Whole Brain Radiotherapy and Iniparib in Multiple Non Operable Brain Metastases Phase 1
Terminated NCT00717275 - Study of Temozolomide to Treat Newly Diagnosed Brain Metastases Phase 2
Recruiting NCT05048212 - A Phase II Study of Nivolumab With Ipilimumab and Cabozantinib in Patients With Untreated Renal Cell Carcinoma Brain Metastases Phase 2
Recruiting NCT03714243 - Blood Brain Barrier Disruption (BBBD) Using MRgFUS in the Treatment of Her2-positive Breast Cancer Brain Metastases N/A
Recruiting NCT05573815 - Evaluation of Clinical Decision Support System for Brain Metastasis Using Brain MR Images N/A
Recruiting NCT04899908 - Stereotactic Brain-directed Radiation With or Without Aguix Gadolinium-Based Nanoparticles in Brain Metastases Phase 2
Completed NCT04507217 - Tislelizumab Combined With Pemetrexed/ Carboplatin in Patients With Brain Metastases of Non-squamous NSCLC Phase 2
Recruiting NCT05452005 - Fluorine-18-AlphaVBeta6-Binding Peptide Positron Emission Tomography in Metastatic Non-Small Cell Lung Cancer Phase 1
Recruiting NCT06457906 - SRS/SRT/Hypo-RT Versus HA-WBRT for No More Than 10 Brain Metastases in SCLC Phase 3
Completed NCT04170777 - Perfexion Registration Using CBCT
Recruiting NCT03027544 - Tomotherapy for Refractory Brain Metastases N/A
Completed NCT04178330 - Tomotherapy as Primary Radiotherapy for Multipule Brain Metastases N/A
Terminated NCT02187822 - Fractionated Stereotactic Radiotherapy (FSRT) in Treatment of Brain Metastases Phase 1
Terminated NCT00538343 - RTA 744 in Breast Cancer Patients With Progression of Previously Irradiated Brain Metastases Phase 2