Clinical Trial Details
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[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT03115333 : DSC-MRI in Measuring Relative Cerebral Blood Volume for Early Response to Bevacizumab in Patients With Recurrent Glioblastoma
PhasePhase 2
AgesMin: 18 Years Max: N/A
Eligibility
Inclusion Criteria:

- Histologically proven intracranial glioblastoma or gliosarcoma at initial surgery

- Patients will be eligible if the original histology was low-grade glioma and a
subsequent diagnosis of glioblastoma or gliosarcoma is made (high-grade
transformation)

- Karnofsky performance status >= 70

- Women must not be pregnant or breast-feeding

- Progression of disease assessed by local site using Revised Assessment in
Neuro-Oncology (RANO) criteria, with plan to give whole-dose bevacizumab
therapeutically, either as single therapy or in conjunction with other
chemotherapeutic regimens; patients getting bevacizumab to support additional
radiation therapy or immunotherapy, or primarily for reduction of edema rather than
for tumor treatment, are excluded; this must be the patient?s initial recurrence

- Patient must not have been treated previously with immunotherapies (vaccines,
checkpoint inhibitors, T-cells)

- Intratumoral hemorrhage (acute, subacute, or chronic) as seen on hemosiderin-sensitive
(gradient-echo) MRI may preclude patient inclusion because of anticipated limited
evaluation due to magnetic susceptibility artifact on the heavily T2-weighted DSC-MRI
images; if the region of enhancing tumor not affected by blooming artifact on the
hemosiderin-sensitive images does not meet the 10 x 10 x 10 mm ?measurable
enhancement? threshold specified elsewhere, the patient is ineligible

- Progressive enhancement (> 25% increase in contrast enhancing volume compared to
nadir) on MRI within 14 days of registration, >= 42 days since completion of
radiation/temozolomide therapy, and >= 28 days since surgical resection or cytotoxic
chemotherapy; measurable enhancement is defined as two perpendicular in-plane
diameters of at least 10 mm and at least 10 mm in the 3rd orthogonal direction

- Patients must be able to tolerate brain MRI scans with dynamic intravenous
gadolinium-based contrast agent injections

- Ability to withstand 22 gauge intravenous (IV) placement

- No history of untreatable claustrophobia

- No magnetic resonance (MR) incompatible implants/devices or metallic foreign
bodies

- No contraindication to intravenous contrast administration

- Adequate organ function, including adequate renal function defined as
estimated glomerular filtration rate (eGFR) >= 40 mL/min/1.73 m^2 as
calculated per institution standard of care, and meeting local site
requirements for intravenous administration of gadolinium-based MRI contrast
agents

- No known allergy-like reaction to gadolinium or moderate or severe allergic
reactions to one or more allergens as defined by the American College of
Radiology (ACR); patient may be eligible if willing to undergo pre-treatment as
defined by the institution's policy and/or ACR guidance

- Weight compatible with limits imposed by the MRI scanner table

- Patient must be scheduled to receive treatment with a standard dose regimen of
bevacizumab (bevacizumab infusion on days 1 and 15 of a 28-day treatment cycle);
patient can be treated with bevacizumab alone or in combination with other
chemotherapies
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT03115333      |      Link to official Clinicaltrials.gov listing
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