Clinical Trial Details
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NCT03276676 : [18F]Fluciclovine and [18F]FLT PET/CT Assessment of Primary High-Grade Brain Tumors
PhasePhase 2
AgesMin: 18 Years Max: N/A
Inclusion Criteria:

- Two adult patient groups will be eligible for inclusion in this study:

Group A: Patients where there is compelling evidence, based on the MRI and/or CT imaging,
that a high-grade primary brain tumor is present. Pathologic confirmation will occur with
biopsy or surgery.

Patients whose tumor is felt to be inoperable and a biopsy is performed but no surgery.

Patients with a newly diagnosed primary malignant brain tumor (WHO Grade III or IV) who
will be receiving chemoradiation and who either did not undergo surgical resection or
underwent incomplete resection with residual tumor > 1.0 cm in greatest diameter by
contrast MRI postoperatively.

Group B: Patients with pathologically proven malignant brain tumor (WHO Grade III or IV
glial-based tumors) who have undergone chemoradiation and have MRI-documented possible
recurrence/progression versus treatment effect (pseudoprogression) within 6 months from the
time of completion of chemoradiation.

- Patients must be 18 years or older for inclusion in this study. There is little
experience with the safety of [18F]FLT or [18F]Fluciclovine in children, and the risks
associated with radiation exposure may be increased for children under 18 years old as

- Patients must document their willingness to be followed for at least 24 months after
recruitment by signing informed consent documenting their agreement to have clinical
endpoints and the results of histopathologic tissue analysis (when tissue becomes
available from routine care) entered into a research database.

- All patients, or their legal guardians, must sign a written informed consent and HIPAA
authorization in accordance with institutional guidelines.

- Determination of pregnancy status: Female patients who are not postmenopausal or
surgically sterile will undergo a serum pregnancy test prior to each set of [18F]FLT
and [18F]Fluciclovine PET scans. A negative test will be necessary for such patients
to undergo research PET imaging.

- Pre-imaging laboratory tests must be performed within 28 days prior to the [18F]FLT
imaging procedure. These must be less than 4.0 times below or above the upper or lower
limit range for the respective laboratory test for entry into the study (unless
clinically not relevant). In those instances where a laboratory value is outside of
this range, then such a patient will be ineligible for enrollment. For follow-up
scanning sessions after therapy has been instituted, laboratory testing will also be
required due to the use of [18F]FLT. The patients have brain tumors and will have
received chemoradiation; therefore, many routine laboratory tests may not be within
the typical normal range. As such, a factor of 4.0 times above or below the upper or
lower value for the normal range for any laboratory test will also be used to
determine the acceptable range for the 2nd and possibly 3rd imaging time points
(unless clinically not relevant). The baseline laboratory testing will include liver
enzymes (ALT, AST), bilirubin (total), serum electrolytes, CBC with platelets,
prothrombin time, partial thromboplastin time, BUN, and creatinine. For those patients
receiving coumadin or another anticoagulant the upper limit for prothrombin time or
partial thromboplastin time must not exceed 6 times the upper limit of the normal
range. (Appendix E, Laboratory Study Results).

Exclusion Criteria:

- Patients with clinically significant signs of uncal herniation, such as acute
pupillary enlargement, rapidly developing motor changes (over hours), or rapidly
decreasing level of consciousness, are not eligible.

- Patients with known allergic or hypersensitivity reactions to previously administered
radiopharmaceuticals. Patients with significant drug or other allergies or autoimmune
diseases may be enrolled at the Investigator's discretion.

- Patients who are pregnant or lactating or who suspect they might be pregnant. Serum
pregnancy tests will be obtained prior to each set of multi-tracer PET scans in female
patients that are not postmenopausal or surgically sterile.

- Adult patients who require monitored anesthesia for PET scanning.

- Patients who are too claustrophobic to undergo PET scanning.

- Known HIV positive patients due to the previous toxicity noted with [18F]FLT in this
patient group.
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