CBF and NCF Changes With Brain Radiation

Conditions de participation

• Sexe:

  ALL

• Âges admissibles:

  18 and up

Critères de participation

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.