(11C)dLop as a Marker of P-Glycoprotein Function in Patients With Gliomas

NCT01281982 | Terminated

• 2 other identifiers: 11008111-C-0081
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Low Grade Glioma; Glioblastoma Multiforme; Anaplastic Astrocytoma; Anaplastic Oligodendroglioma; Oligoastrocytoma

Keywords

Imaging; Gliomas; Pet Scan; Blood Brain Barrier; P-Glycoprotein; Brain Tumor; Glioma; Glioblastoma Multiforme; Astrocytoma

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with histologically proven intracranial glioma will be eligible for this protocol. Eligible histologies include glioblastoma multiforme (GBM), gliosarcoma (GS), anaplastic astrocytoma (AA), anaplastic oligodendroglioma (AO), anaplastic mixed oligoastrocytoma (AMO), malignant astrocytoma NOS (not otherwise specified), low grade astrocytoma (LGA), low grade oligoastocytoma (LOA), and low grade oligodendroglioma (LGO). Patients with radiographically diagnosed or suspected low grade glioma will also be eligible.
• Patients having undergone recent resection will be eligible as long as all of the following conditions apply:
• They have recovered from the effects of surgery, not to have been performed within 2 weeks of the study scan.
• Residual enhancing or non-enhancing disease following resection of recurrent tumor is mandated for eligibility into the study. To best assess the extent of residual disease post-operatively, a CT/ MRI should be done:
• no later than 96 hours in the immediate post-operative period, or
• at least 4 weeks post-operatively, and
• within 14 days of registration, and
• on a steroid dosage that has been stable for at least 5 days.
• Normal organ and marrow function defined as: total leukocyte count greater than or equal to 3000 cells/ul, ANC greater than or equal to 1500 cells/ul, platelet count greater than or equal to 100,000 cells/ul, serum creatinine less than or equal to 2.0 X upper limit of normal, and bilirubin less than or equal to 1.5X upper limit of normal, hemoglobin greater than or equal to 9.0 g/dL , serum calcium less than12.0 mg/dL, AST/ALT less than or equal to1.5 times the upper limit of normal, PT less than or equal to1.5 ULN.
• All patients or their previously designated DPA (if the patient is deemed by the treating physician to be impaired or questionably impaired in such a way that the ability of the patient to give informed consent is questionable) must sign an informed consent indicating that they are aware of the investigational nature of this study.
• Patients must be greater than or equal to 18 years old.
• Patients must have a Karnofsky performance status of greater than or equal to 60.
• Patients must not have any significant medical illnesses that in the investigator s opinion cannot be adequately controlled with appropriate therapy or would compromise the patients ability to tolerate this study.

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.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Hochberg FH, Pruitt A. Assumptions in the radiotherapy of glioblastoma. Neurology. 1980 Sep;30(9):907-11. doi: 10.1212/wnl.30.9.907.

  PMID: 6252514 BACKGROUND

• Bloom HJ. Combined modality therapy for intracranial tumors. Cancer. 1975 Jan;35(1):111-20. doi: 10.1002/1097-0142(197501)35:13.0.co;2-#.

  PMID: 162849 BACKGROUND

• Salazar OM, Rubin P, McDonald JV, Feldstein ML. High dose radiation therapy in the treatment of glioblastoma multiforme: a preliminary report. Int J Radiat Oncol Biol Phys. 1976 Jul-Aug;1(7-8):717-27. doi: 10.1016/0360-3016(76)90155-3. No abstract available.

  PMID: 185174 BACKGROUND

MeSH Terms

Conditions

Glioblastoma; Astrocytoma; Oligodendroglioma; Glioma; Brain Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Teri N Kreisl, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2011
• First Posted: January 24, 2011
• Study Start: January 13, 2011
• Study Completion: September 24, 2012
• Last Updated: July 5, 2018

Record last verified: 2012-09-24

Locations

US (1)