(11C)dLop as a Marker of P-Glycoprotein Function in Patients With Gliomas
Stopped early
Conditions studied: Low Grade Glioma, Glioblastoma Multiforme, Anaplastic Astrocytoma, Anaplastic Oligodendroglioma, Oligoastrocytoma
In brief
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.
Key facts
- Study ID
- NCT01281982
- Run by
- National Cancer Institute (NCI)
- People needed
- 2
- Starts
- 2011-01-13
- Expected to finish
- 2012-09-24
- Last updated by the study team
- 2018-07-05
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Patients who, in the view of the treating physician, have significant active cardiac, hepatic, renal, or psychiatric diseases are ineligible.
- Patients who have an active infection.
- Pregnant (positive pregnancy test) or nursing women.
- Patients cannot take loperamide within three days of (11C)dLop imaging.
- Concurrent use of a Pgp inducer as listed in Appendix A within 2 weeks of a study scan. Use of these medications is allowed over the course of participation in the study, but must not be administered within 2 weeks of the study imaging.
- Prior participation in other research protocols or clinical care in the last year such that radiation exposure, including that from this protocol, would exceed the guidelines set by the Radiation Safety Committee (RSC).
- Patients who have any contraindication to gadolinium enhanced MRI.
Where it is running
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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