Trial Information

A Pilot, Non-Therapeutic NeuroImaging Study of 18F-FLT in Pediatric Patients With Newly Diagnosed Central Nervous System Tumors

Patients will undergo standard pre-diagnostic imaging of the sites of disease using standard
MRI techniques. If disease is suspected in both the brain and spine, then both imaging
modalities should be obtained. This imaging should be obtained no more than 21 days before
surgical resection. As close as possible to the completion of the MRI scans, patients will
undergo 18F-FLT imaging using a single administration of tracer, and PET image acquisition
at four different time points (baseline, 1 hr post injection, 2 hrs post injection and 4-6
hours post injection). A whole body PET scan (top of the head to mid thigh) will be
performed immediately after injection (PET acquisition #1). These data will be acquired
with a 2 minute emission and a 2 minute transmission scan at each bed position. Following
this acquisition, the subject will empty his or her bladder. At 45 minutes post-injection,
a brain and/or spine (body) PET scan will be acquired with a 10 min emission scan and a 5
min transmission scan (PET acquisition #2). This scan will include all areas of suspected
tumor (brain, spine, or brain and spine). Following PET acquisition #2, a whole body PET
scan will be acquired according to the same protocol as above (PET acquisition #3). If
possible, a final whole body scan will be acquired 4-6 h post-injection (PET acquisition
#4). All PET acquisitions will be acquired in 3D mode and reconstructed with the FORE
re-binned OSEM algorithm with measured attenuation correction. Blood samples will be
obtained at the completion of each whole body scan. Patients will receive the dose of
18F-FLT through a fresh intravenous catheter as per standard PET procedures. Patients will
then undergo maximal surgical resection. Pieces from different areas of the tumor will be
marked for correlation to imaging studies when possible. Tumor samples will undergo standard
immunohistochemical analysis for cellular activation including mitotic index and MIB-1
proliferation staining.

Serial blood draws will also be obtained at four different time points (baseline, 1 hr post
injection, 2 hrs post injection, and 4-6 hours post injection) to evaluate clearance of
18F-FLT from the blood.

For the biodistribution, the 3D regions of interest (ROIs) will be drawn about each major
organ that is identified on the whole body scans. This will be performed on each of the
whole body scans and a time activity curve will be generated. The residence time for each
organ will be determined. The blood data will be pipetted and counted for estimates of
activity in the blood and bone marrow. For the brain and/or spine images, the PET data will
be registered to the subjects' MRI. The PET scan will be graded on a subjective 4-point
scale. 3D ROIs will be drawn around the tumor. In addition, an analogous ROI will be drawn
in normal brain background and about the whole brain for comparison. For the tumor,
tumor-to-background, tumor-to-whole brain ratios will be determined. In addition, standard
uptake values (SUVs) will be determined for the tumor and background.