Trials / Terminated
TerminatedNCT00253461
11C Topotecan PET Imaging
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
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 7 (actual)
- Sponsor
- Case Comprehensive Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | computed tomography | Within 4 weeks after initial imaging, patients also undergo a CT scan. |
| PROCEDURE | positron emission tomography | Phase I: IV over 10 minutes followed immediately by a 1-2 hour positron emission tomography (PET) scan. Phase II: fludeoxyglucose F 18 IV and, 1 hour later, undergo a PET scan. |
| RADIATION | 11C topotecan | Phase I and II: IV over 10 minutes |
| RADIATION | fludeoxyglucose F 18 | Phase II: fludeoxyglucose F 18 IV |
Timeline
- Start date
- 2004-12-01
- Primary completion
- 2009-11-01
- Completion
- 2009-11-01
- First posted
- 2005-11-15
- Last updated
- 2012-03-20
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00253461. Inclusion in this directory is not an endorsement.