(11C)dLop as a Marker of P-Glycoprotein Function in Patients With Gliomas
|First Received Date ICMJE||January 21, 2011|
|Last Updated Date||May 3, 2013|
|Start Date ICMJE||January 2011|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT01281982 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||(11C)dLop as a Marker of P-Glycoprotein Function in Patients With Gliomas|
|Official Title ICMJE||(11C)N-Desmethyl-Loperamide as a Marker of P-Glycoprotein Function in Patients With Gliomas|
- 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.
- To study the ability of PET imaging with (11C)dLop to evaluate the blood brain barrier in brain tumor patients.
- 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.
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.
-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
Patients with predominantly non-enhancing intracranial gliomas will be eligible.
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.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Time Perspective: Prospective|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Terminated|
|Completion Date||September 2012|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT01281982|
|Other Study ID Numbers ICMJE||110081, 11-C-0081|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )|
|Study Sponsor ICMJE||National Cancer Institute (NCI)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||September 2012|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP