Ignite Creation Date:
2025-12-24 @ 12:05 PM
Ignite Modification Date:
2025-12-27 @ 10:13 PM
Study NCT ID:
NCT00253461
Status:
TERMINATED
Last Update Posted:
2012-03-20
First Post:
2005-11-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
11C Topotecan PET Imaging
Sponsor:
Case Comprehensive Cancer Center
Organization:
Study Overview
Official Title:
Positron Emission Tomography Using 11C Topotecan in Predicting Response to Treatment in Patients With Brain Metastases Due to Ovarian, Small Cell Lung, or Other Cancer
Status:
TERMINATED
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Drugs unavailable:unable to make radioactive topotecan
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE: Diagnostic procedures, such as positron emission tomography (PET scan) using 11C topotecan, may help doctors predict a patient's response to treatment and help plan the best treatment.
PURPOSE: This phase I/II trial is studying how well a PET scan using 11C topotecan predicts response to treatment in patients with brain metastases due to ovarian, small cell lung, or other cancer.
PURPOSE: This phase I/II trial is studying how well a PET scan using 11C topotecan predicts response to treatment in patients with brain metastases due to ovarian, small cell lung, or other cancer.
Detailed Description:
OBJECTIVES:
Primary
* Determine if tumor uptake of \^11C topotecan occurs quickly enough and at sufficient concentration to be measured immediately following infusion in patients with brain metastases secondary to ovarian cancer, small cell lung cancer, or other cancers.
* Determine, preliminarily, if \^11C imaging has potential to be an early predictor of response to topotecan therapy in these patients.
Secondary
* Determine the whole-body biodistribution of \^11C topotecan in these patients.
OUTLINE:
* Phase I: Patients receive \^11C topotecan IV over 10 minutes followed immediately by a 1-2 hour positron emission tomography (PET) scan. Within 4 weeks after initial imaging, patients also undergo a CT scan.
* Phase II: Patients receive \^11C topotecan and undergo imaging as in phase I. Patients also receive fludeoxyglucose F 18 IV and, 1 hour later, undergo a PET scan.
PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study.
Primary
* Determine if tumor uptake of \^11C topotecan occurs quickly enough and at sufficient concentration to be measured immediately following infusion in patients with brain metastases secondary to ovarian cancer, small cell lung cancer, or other cancers.
* Determine, preliminarily, if \^11C imaging has potential to be an early predictor of response to topotecan therapy in these patients.
Secondary
* Determine the whole-body biodistribution of \^11C topotecan in these patients.
OUTLINE:
* Phase I: Patients receive \^11C topotecan IV over 10 minutes followed immediately by a 1-2 hour positron emission tomography (PET) scan. Within 4 weeks after initial imaging, patients also undergo a CT scan.
* Phase II: Patients receive \^11C topotecan and undergo imaging as in phase I. Patients also receive fludeoxyglucose F 18 IV and, 1 hour later, undergo a PET scan.
PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| P30CA043703 | NIH | None | https://reporter.nih.gov/quic… | View |
| CASE-CWRU-6Y02 | OTHER | Case Comprehensive Cancer Center | View |