CBF and NCF Changes With Brain Radiation

Launched by UNIVERSITY HEALTH NETWORK, TORONTO · Jul 27, 2018

Keywords

ClinConnect Summary

This clinical trial is investigating how radiation therapy affects brain function and cognitive abilities in patients with brain metastases, which are cancerous growths that spread to the brain from other parts of the body. The study will compare two types of radiation treatment: Stereotactic Radiosurgery (SRS), which targets specific tumors, and Whole Brain Radiation Therapy (WBRT), which treats the entire brain. Researchers will also use a special MRI technique to look for changes in the brain that might indicate a decline in cognitive function over time.

To participate, patients must have been diagnosed with brain metastases confirmed by MRI, with 1 to 10 lesions that are not planned for surgical removal, and no prior radiation treatment for brain tumors. Participants will undergo assessments of their cognitive abilities before starting radiation and will continue to be monitored for two years afterward. This study is open to adults aged 65 and older, and those who can provide informed consent. It's important for potential participants to understand that they will need to be available for treatments and follow-up evaluations.

Gender

ALL

Eligibility 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.