Preliminary Evaluation of the Efficacy of [F-18] Fluorothymidine (FLT) to Differentiate Radiation Necrosis From Tumor Recurrence and as a Marker of Proliferation in Patients With Primary Brain Tumors
The primary objective of this study is to assess the preliminary efficacy of the
radiopharmaceutical 3'-deoxy-3'-[F-18]fluorothymidine, [F-18]FLT, a radiopharmaceutical that
directly assess tumor proliferation using Positron Emission Tomography (PET) in
differentiating tumor recurrence from radiation necrosis in a group of 30 patients with
glial neoplasms. This preliminary clinical study will investigate [F-18]FLT in patients with
previously treated primary malignant brain tumors (WHO Grade II, III or IV glial-based
tumors) who have a new or enlarging enhancing lesion on Gd-MRI and in whom it is not
possible to differentiate recurrent tumor from radiation necrosis on the basis of
conventional imaging techniques. The ability to make this important differentiation and
accurately determine the amount/degree of tumor recurrence from the amount/degree of
radiation necrosis in the enhancing mass is critical for the care of treated brain tumor
patients and could potentially change patient management once validated as an accurate means
of differentiating the amount/degree of radiation necrosis from recurrence.
While the safety of [F-18]FLT has been studied in a many patients to date we will also
obtain additional safety data on the use of this agent in patients with primary brain tumors
in a cohort of the initial 12 patients to be studied. It is important to emphasize that the
potential clinical application of [F-18]FLT imaging in brain tumors must be compared to the
current widely used imaging techniques of MRI and PET imaging using the agent, [F-18]
fluorodeoxyglucose (FDG).
In this study, [F-18]FLT PET will be used to assess the three goals of this project:
1. Show that imaging with [F-18]FLT and PET will or will not better determine the
amount/degree of tumor versus necrosis in the abnormal areas seen on the recent MRI
scan and FDG-PET scan.
2. The [F-18]FLT radiopharmaceutical is shown to be safe or not safe in the amount
administered in this study.
3. The amount of [F-18]FLT that is seen on the PET study is shown to correlate or not to
correlate with other tests used to determine the proliferation of brain tumors in a
tissue sample of your newly identified abnormality on MRI in the event that another
surgical biopsy or procedure is performed
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Show that imaging with [F-18]FLT and PET will or will not better determine the amount/degree of tumor versus necrosis in the abnormal areas seen on the recent MRI scan and FDG-PET scan
December 2011
No
John M Hoffman, MD
Principal Investigator
Huntsman Cancer Institute
United States: Food and Drug Administration
HCI20112
NCT00707343
May 2007
December 2013
Name | Location |
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Huntsman Cancer Institute | Salt Lake City, Utah 84112 |