Glioblastoma Multiforme Clinical Trial
Official title:
(11C)N-Desmethyl-Loperamide as a Marker of P-Glycoprotein Function in Patients With Gliomas
Background:
- The blood-brain barrier helps to protect the central nervous system (brain and spinal cord)
from harmful toxins, but also prevents potentially useful chemotherapy from reaching brain
tumors. The barrier is formed by tight connections between blood vessel cells and molecules
found on the surface of brain blood vessels such as Permeability-glycoprotein (Pgp). Pgp may
influence whether patients with brain tumors known as gliomas respond to chemotherapy and
what side effects they may experience. The compound (11C)N-desmethyl-loperamide ((11C)dLop)
reacts to Pgp molecules, and therefore may be used with positron emission tomography (PET)
imaging to study the blood brain barrier.
Objectives:
- To study the ability of PET imaging with (11C)dLop to evaluate the blood brain barrier in
brain tumor patients.
Eligibility:
- Individuals at least 18 years of age who have a brain tumor with characteristics that may
be imaged with techniques such as magnetic resonance imaging (MRI) andPET.
Design:
- Participants will be screened with a full physical examination and medical history,
blood and urine tests, and tumor imaging studies (fluorodeoxyglucose PET and MRI scans
with contrast agent).
- The (11C)dLop scan will take 1 hour to perform. Participants will be asked to return for
blood and urine tests approximately 24 hours after the PET scan.
- Participants will have followup visits at least every 4 months by repeating a complete
history and physical exam and brain MRI. Participants may have repeat scans with
(11C)dLop at various points in the course of cancer treatment, but will not have these
scans more than twice in a 12-month period.
- Participants will be followed for as long as possible during treatment to see if imaging
with (11C)dLop correlates with response to the treatments.
BACKGROUND:
A potential impedance to successful glioma chemotherapy is sanctuary for tumor behind the
blood brain barrier. P-glycoprotein (Pgp) is an efflux transporter encoded by MDR1 that
contributes to the functional regulation of substrates across the cerebrovasular endothelium.
Pgp activity in patients with gliomas may influence response to therapy and neurotoxicity.
(11C) N-desmethyl-loperamide (11C)dLop) is a radioligand substrate for Pgp, and PET imaging
with this molecular marker may provide a non-invasive, in vivo method of examining Pgp
function in brain tumor patients.
OBJECTIVES:
Primary:
-To measure the uptake of (11C)N-desmethyl-loperamide ((11C)dLop) using PET imaging as a
marker of Pglycoprotein function in patients with intracranial gliomas
Secondary:
- Correlate (11C)dLop PET uptake with perfusion MRI parameters and FDG PET uptake for
volumes of interest (VOI) determined by the baseline MRI
- Develop exploratory data for the correlation of (11C)dLop PET imaging with patient
outcomes such as response to therapy, survival, and neurotoxicity
- Develop exploratory data for the correlation of (11C)dLop PET imaging with
immunohistochemical and molecular genomic assays of MDR1 and Pgp
ELIGIBILITY:
Patients with predominantly non-enhancing intracranial gliomas will be eligible.
DESIGN:
This is a pilot study of (11C)dLop PET imaging in 10 patients with intracranial glioma.
Standard uptake values (SUVs) corrected for cerebral blood flow determined by (15O)H20 PET
scans will be correlated to DCE-MRI (obtained within prior 2 weeks) and FDG-PET (obtained
within prior 4 weeks) to characterize locoregional differences in Pgp function. When
available, correlative studies performed on archived tumor tissue acquired immediately
subsequent to (11C)dLop scanning will include immunohistochemical assays of Pgp expression,
as well as characterization of MDR1 polymorphisms. Patient case histories will be followed
longitudinally to make observations about how (11C)dLop imaging may correlate with patient
outcomes such as response to therapy, survival, and neurotoxicity.
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