Assessment of Suspected Intracranial Malignancy Using 3'-Deoxy-3'18 F-flourothymidine PET

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. Identifier: NCT00775320
Recruitment Status : Terminated (Study closed by institutional review board)
First Posted : October 20, 2008
Last Update Posted : May 16, 2016
Midwest Medical Isotopes
Information provided by (Responsible Party):
Jennifer Holter, University of Oklahoma

Brief Summary:
The primary objective of this study is to detect and quantify tumor cells of high grade malignant gliomas and metastatic brain lesions both before and after initial surgical resection in a cohort of newly diagnosed patients.

Condition or disease Intervention/treatment
Brain Tumor Procedure: FLT-PET scan

Detailed Description:
In this study, 35 patients will be selected to undergoing sequential imaging with FLT-PET. Prior to surgical resection, patients will undergo a preliminary FLT-PET. Additional FLT scans for a maximum of four scans.

Study Type : Observational
Actual Enrollment : 13 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Assessment of Suspected Intracranial Malignancy Using 3'-Deoxy-3'18 F-fluorothymidine Positron Emission Tomography
Study Start Date : October 2008
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors
U.S. FDA Resources

Group/Cohort Intervention/treatment
Brain tumor FLT-PET
Those diagnosed with a brain tumor and are to undergo surgery
Procedure: FLT-PET scan
Imaging test

Biospecimen Retention:   Samples Without DNA
Tissue from brain tumor

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subjects diagnosed with a brain tumor and to undergo surgery

Inclusion Criteria:

  • 18 years or older
  • Women must not be pregnant or breast feeding
  • Histologic or strong radiologic suspicion of high grade malignant glioma or ogliometastatic tumor(s)

Exclusion Criteria:

  • May not have received previous therapy for their malignancy

Information from the National Library of Medicine

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 identifier (NCT number): NCT00775320

United States, Oklahoma
University Of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
University of Oklahoma
Midwest Medical Isotopes
Principal Investigator: Jennifer Holter, MD Assistant Professor

Responsible Party: Jennifer Holter, Associate Professor, University of Oklahoma Identifier: NCT00775320     History of Changes
Other Study ID Numbers: FLT- Brain Study
First Posted: October 20, 2008    Key Record Dates
Last Update Posted: May 16, 2016
Last Verified: May 2016

Keywords provided by Jennifer Holter, University of Oklahoma:
Brain scan