Clinical Trial Details
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NCT02370563 : PET Imaging of Intracranial Cancers With 18F-FSPG
PhasePhase 1
AgesMin: 18 Years Max: N/A
Inclusion Criteria:

1. Written informed consent

2. Participant must be able to complete a PET/CT scan and MRI without the use of

3. Participant has

- a primary brain tumor that has been histologically confirmed

- OR confirmed or suspected recurrent brain cancer or brain metastasis for which
the primary tumor has been histologically confirmed,

- OR a brain lesion that is concerning for malignancy for which histopathological
confirmation is anticipated following enrollment (e.g., biopsy or surgical
resection of the tumor is scheduled)

- OR a suspected low-grade brain tumor, where confirmation is based upon a
combination of other imaging (e.g. PET/CT, MRI, diagnostic CT) and clinical

- All pathology specimens must be within 1 year of the planned 18F-FSPG PET/CT

4. The time interval between 18F-FSPG PET/CT and other imaging (including other PET/CTs,
MRI or diagnostic CT) should be within 4 weeks (exceptions will be allowed for 6
weeks, if there are no other options)

5. Karnofsky Performance Status Scale of 60 or higher OR an ECOG Performance Status of

6. No clinically relevant deviations in renal function (Serum Creatinine > Grade 2 CTCAE
v4.0.). Maximal interval between confirmation and injection of 18F-FSPG is one week.

7. No chemotherapy, radiotherapy, or immune/biologic therapy scheduled or performed
between other imaging (PET/CTs, MRI, or diagnostic CTs) and18F-FSPG PET/CT.

Exclusion Criteria:

1. Patient is scheduled for brain surgery and/or another invasive procedure within the
time period of one month prior to 18F-FSPG administration. Minimally invasive needle
biopsies are allowed.

2. Known hypersensitivity to the study drug or components of the preparation

3. Patient has completed participation in another clinical study involving
administration of an investigational agent in the preceding 4 weeks. However,
participation in clinical studies involving other investigational PET or SPECT
tracers will not be excluded if in the opinion of the Investigator:

- evaluation of 18F-FSPG safety and tolerability will not be confounded by the
other investigational PET or SPECT tracer

- a minimum of two days (or longer as necessary based on radiological half-life)
have elapsed between investigational PET or SPECT tracer administrations to
allow acceptable clearance of the tracer

- the investigational PET or SPECT tracer administration was well tolerated by the

4. Investigator precludes participation for scientific reasons, for reasons of
compliance (e.g., concurrent disease which could compromise the subject's study
completion), or for reasons of the patient's safety
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