Clinical Trials Directory

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

TypeNameDescription
PROCEDUREcomputed tomographyWithin 4 weeks after initial imaging, patients also undergo a CT scan.
PROCEDUREpositron emission tomographyPhase 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.
RADIATION11C topotecanPhase I and II: IV over 10 minutes
RADIATIONfludeoxyglucose F 18Phase 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.