TerminatedNot Applicable

MRI Scans in Evaluating the Effects of Radiation Therapy and Chemotherapy in Patients With Newly Diagnosed Glioblastoma Multiforme or Anaplastic Glioma

Stopped: Funding ended

United States15 participantsStarted 2008-07

Plain-language summary

RATIONALE: Diagnostic procedures, such as MRI, may help in learning how well radiation therapy and chemotherapy work in killing tumor cells and allow doctors to plan better treatment. PURPOSE: This clinical trial is studying MRI scans to see how well they evaluate the effects of radiation therapy and chemotherapy in patients with newly diagnosed glioblastoma multiforme or anaplastic glioma.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

DISEASE CHARACTERISTICS: * Newly diagnosed anaplastic glioma (WHO grade III) or glioblastoma multiforme (WHO grade IV) * Measurable disease * Residual tumor size after surgery ≥ 1 cm in one dimension * Planning to undergo standard chemoradiotherapy with temozolomide PATIENT CHARACTERISTICS: * Glomerular filtration rate ≥ 60 mL/min * Mini Mental Status Exam score \> 15 * Sufficiently competent to give informed consent * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective barrier contraception during and for 2 months after completion of study treatment * No contraindication to MRI or to use of the contrast agent gadolinium, including any of the following: * Claustrophobia * Metallic objects or implanted medical devices (e.g., cardiac pacemaker, aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants) * Sickle cell disease * Renal failure * High risk for kidney disease (e.g., age \> 60 years, diabetes, or history of systemic lupus erythematosus or multiple myeloma) * No known history of chronic obstructive pulmonary disease or emphysema * No other co-existing condition that, in the judgement of the investigator, may increase risk to the patient PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Non-VEGF investigational agent allowed * No concurrent chemotherapy (other than temozolomide) * No concurrent electron, proton, …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Relative Cerebral Blood Volume as Measured by Perfusion-weighted MRI Before, During, and After Chemoradiotherapy

Timeframe: Baseline, weekly during treatment, monthly following treatment for up to six months

Relative Cerebral Blood Flow as Measured by Perfusion-weighted MRI Before, During, and After Chemoradiotherapy

Timeframe: Baseline, weekly during treatment, monthly following treatment for up to six months

Vessel Diameter as Measured by Perfusion-weighted MRI Before, During, and After Chemoradiotherapy

Timeframe: Baseline, weekly during treatment, monthly following treatment for up to six months

Mean Transit Time as Measured by Perfusion-weighted MRI Before, During, and After Chemoradiotherapy

Timeframe: Baseline, weekly during treatment, monthly following treatment for up to six months

Permeability-surface Area Product Before, During, and After Chemoradiotherapy

Timeframe: Baseline, weekly during treatment, monthly following treatment for up to six months

Apparent Diffusion Coefficient Before, During, and After Chemoradiotherapy

Timeframe: Baseline, weekly during treatment, monthly following treatment for up to six months

Trial details

NCT IDNCT00756106

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-02

Results submitted2020-03-23

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