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

This study has been terminated.
(Study closed by institutional review board)
Sponsor:
Collaborator:
Midwest Medical Isotopes
Information provided by:
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT00775320
First received: October 17, 2008
Last updated: September 27, 2010
Last verified: September 2010
  Purpose

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 Intervention
Brain Tumor
Procedure: FLT-PET scan

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Assessment of Suspected Intracranial Malignancy Using 3'-Deoxy-3'18 F-fluorothymidine Positron Emission Tomography

Resource links provided by NLM:


Further study details as provided by University of Oklahoma:

Biospecimen Retention:   Samples Without DNA

Tissue from brain tumor


Estimated Enrollment: 35
Study Start Date: October 2008
Groups/Cohorts Assigned Interventions
Brain tumor FLT-PET
Those diagnosed with a brain tumor and are to undergo surgery
Procedure: FLT-PET scan
Imaging test

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Subjects diagnosed with a brain tumor and to undergo surgery

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00775320

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

No publications provided

Responsible Party: Jennifer Holter, MD, Univeristy of Oklahoma Dept of Medicine
ClinicalTrials.gov Identifier: NCT00775320     History of Changes
Other Study ID Numbers: FLT- Brain Study
Study First Received: October 17, 2008
Last Updated: September 27, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Oklahoma:
Brain scan

ClinicalTrials.gov processed this record on October 19, 2014