11C Topotecan PET Imaging
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00253461|
Recruitment Status : Terminated (Drugs unavailable:unable to make radioactive topotecan)
First Posted : November 15, 2005
Last Update Posted : March 20, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer Metastatic Cancer Ovarian Cancer Unspecified Adult Solid Tumor, Protocol Specific||Procedure: computed tomography Procedure: positron emission tomography Radiation: 11C topotecan Radiation: fludeoxyglucose F 18||Early Phase 1|
- 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.
- Determine the whole-body biodistribution of ^11C topotecan in these patients.
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||December 2004|
|Primary Completion Date :||November 2009|
|Study Completion Date :||November 2009|
Procedure: computed 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.
- Pharmacokinetics on day of positron-emission tomography scan [ Time Frame: Within 1 week of PET ]
- Disease response [ Time Frame: after 1-2 courses of treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00253461
|United States, Ohio|
|Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106-5065|
|Principal Investigator:||Raymond Muzic, PhD||Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center|