Ignite Creation Date:
2024-05-05 @ 11:14 PM
Last Modification Date:
2024-10-26 @ 10:30 AM
Study NCT ID:
NCT01281982
Status:
TERMINATED
Last Update Posted:
2018-07-05
First Post:
2011-01-21
Brief Title:
11CdLop as a Marker of P-Glycoprotein Function in Patients With Gliomas
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
11CN-Desmethyl-Loperamide as a Marker of P-Glycoprotein Function in Patients With Gliomas
Status:
TERMINATED
Status Verified Date:
2012-09-24
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 11CN-desmethyl-loperamide 11CdLop 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 11CdLop 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 11CdLop 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 11CdLop 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 11CdLop correlates with response to the treatments
- 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 11CN-desmethyl-loperamide 11CdLop 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 11CdLop 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 11CdLop 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 11CdLop 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 11CdLop correlates with response to the treatments
Detailed Description:
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 11CdLop 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 11CN-desmethyl-loperamide 11CdLop using PET imaging as a marker of Pglycoprotein function in patients with intracranial gliomas
Secondary
Correlate 11CdLop 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 11CdLop PET imaging with patient outcomes such as response to therapy survival and neurotoxicity
Develop exploratory data for the correlation of 11CdLop 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 11CdLop PET imaging in 10 patients with intracranial glioma Standard uptake values SUVs corrected for cerebral blood flow determined by 15OH20 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 11CdLop 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 11CdLop imaging may correlate with patient outcomes such as response to therapy survival and neurotoxicity
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 11CdLop 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 11CN-desmethyl-loperamide 11CdLop using PET imaging as a marker of Pglycoprotein function in patients with intracranial gliomas
Secondary
Correlate 11CdLop 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 11CdLop PET imaging with patient outcomes such as response to therapy survival and neurotoxicity
Develop exploratory data for the correlation of 11CdLop 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 11CdLop PET imaging in 10 patients with intracranial glioma Standard uptake values SUVs corrected for cerebral blood flow determined by 15OH20 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 11CdLop 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 11CdLop imaging may correlate with patient outcomes such as response to therapy survival and neurotoxicity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 11-C-0081 | None | None | None |