Neoplasms

Nervous System Diseases

All Conditions

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Anticoagulants

All Drugs and Chemicals

Nitric Oxide Donors

Edetic Acid

Pentetic Acid

Diethylenetriamine

Patients will receive partial brain irradiation for malignant or benign brain tumors as standard of care. Patients will also have MRI (Magnetic Resonance Imaging) scans and neuropsychological/QOL (Quality of Life Questionnaire) tests prior during and after RT (Radiation Therapy).

Patients will receive whole brain irradiation for brain metastases as standard of care. Patients will also have MRI (Magnetic Resonance Imaging) scans and neuropsychological/QOL (Quality of Life Questionnaire) tests prior during and after RT (Radiation Therapy).

Whole Brain Irradiation

Partial Brain Irradiation

Neuropsychological Testing

Quality of Life Questionnaire

MRI Assessments include Diffusion Tensor Imaging (DTI)and Gd-DTPA (Diethylenetriamine Pentaacetic Acid - a radioactive tracer injected into the patient and viewed on images).

Magnetic Resonance Imaging (MRI) Assessments

Yue Cao, Ph.D.

This is a study to determine if Magnetic Resonance Imaging (MRI) techniques can detect early changes in white matter (in the brain) and the blood-brain barrier resulting from radiation therapy.

Patients will be assigned to one of two groups based on the type of radiation they will be receiving: whole brain irradiation or partial brain irradiation. Patients will undergo Magnetic Resonance Imaging (MRI) assessments, neurocognitive testing (Quality of Life and Neuropsychological assessments), and clinical evaluation.

MRI Study of Radiation-Induced Damage to White Matter and Blood-Brain-Barrier

Linear mixed models will be used to relate Magnetic Resonance Imagining (MRI) changes and radiation dose.

Changes in Magnetic Resonance Imagining (MRI) assessments will be compared graphically to changes in neurocognitive function and clinical symptoms. Parallel analysis will be conducted on each of the neurocognitive tests to determine if MRI assessments can identify patients at increased risk for later neurocognitive dysfunction.

University of Michigan Rogel Cancer Center

Rare Diseases

Glioblastoma

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Antineoplastic Agents

Temozolomide

Antineoplastic Agents, Alkylating

Alkylating Agents

Stereotactic biopsy of brain tumor, then partial brain irradiation and temozolomide, followed by craniotomy and tumor resection, followed by temozolomide

Neoadjuvant treatment with concurrent temozolomide and radiation therapy, followed by surgery and then further temozolomide.

partial brain irradiation

will be assessed for tumor type and tumor markers

stereotactic biopsy of brain tumor

craniotomy and tumor resection

Lawrence Berk, MD, PhD

Trial to determine the safety of neoadjuvant treatment with concurrent temozolomide and radiation therapy, followed by surgery and then further temozolomide.

Prior to any definitive treatment and after enrollment, the patient will undergo stereotactic biopsy of the lesion to confirm the histology of the lesion and to determine methylated methylguanine methyltransferase (MGMT) status. Standard image-guided stereotactic technique will be used. Patients will be treated with conformal radiation therapy. Temozolomide will be given from the day prior to radiation therapy through the last day of radiation therapy. 4-6 weeks after radiation therapy the patient will undergo craniotomy and maximal safe resection. Temozolomide will continue beginning 4 weeks after surgery.

Imaging:

MRI within 2 weeks prior to the start of the protocol. MRI at 4 weeks after chemoradiation therapy and prior to surgery. MRI within 48 hours after surgery.

MRI after every 2 cycles of chemotherapy and then every 2 months until progression, up to 2 years.

Preoperative Chemoradiation for Glioblastoma

Phase I Pilot Study of Preoperative Chemoradiation for Glioblastoma

comparison of toxicity related to experimental treatment to historical local controls

determination of the feasibility of using standard MGMT activity measurement techniques on stereotactic specimens and comparison of the results with the results from the full resection.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
MRI Study of Radiation-Induced Damage to White Matter and Blood-Brain-Barrier	NCT01988675	Brain Neoplasms	Whole Brain Irr... Partial Brain I... Neuropsychologi... Quality of Life... Magnetic Resona...	18 Years -	University of Michigan Rogel Cancer Center
Preoperative Chemoradiation for Glioblastoma	NCT02092038	Glioblastoma	Temozolomide partial brain i... stereotactic bi... craniotomy and ...	18 Years - 80 Years	Tampa General Hospital
Preoperative Chemoradiation for Glioblastoma	NCT02092038	Glioblastoma	Temozolomide partial brain i... stereotactic bi... craniotomy and ...	18 Years - 80 Years	Tampa General Hospital
MRI Study of Radiation-Induced Damage to White Matter and Blood-Brain-Barrier	NCT01988675	Brain Neoplasms	Whole Brain Irr... Partial Brain I... Neuropsychologi... Quality of Life... Magnetic Resona...	18 Years -	University of Michigan Rogel Cancer Center
Preoperative Chemoradiation for Glioblastoma	NCT02092038	Glioblastoma	Temozolomide partial brain i... stereotactic bi... craniotomy and ...	18 Years - 80 Years	Tampa General Hospital
MRI Study of Radiation-Induced Damage to White Matter and Blood-Brain-Barrier	NCT01988675	Brain Neoplasms	Whole Brain Irr... Partial Brain I... Neuropsychologi... Quality of Life... Magnetic Resona...	18 Years -	University of Michigan Rogel Cancer Center

Spots Global Cancer Trial Database for partial brain irradiation