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A Phase I, Open Label, Single Center Safety Study of [F-18]FLT

Phase 1
18 Years
Not Enrolling
Brain Cancer

Thank you

Trial Information

A Phase I, Open Label, Single Center Safety Study of [F-18]FLT

This is a ten subject, phase 1 study. The purpose of the study is to demonstrate drug safety
in a group with high grade brain tumors and to evaluate cell proliferation with F-18 FLT.
FLT is known to clear out of normal brain and detect brain tumor. This population represents
a potential clinical population that may benefit from this PET imaging tracer. This
information will help improve the design and conduct of future F-18 FLT clinical trials.

Inclusion Criteria:

- Subject may be male or female and of any race / ethnicity;

- At the time of study drug dosing, the subject has reached his or her 18th birthday;

- Subject has histologic diagnosis of one of the following malignancies - glioblastoma
gliosarcoma, anaplastic mixed/anaplastic oligodendroglioma or (anaplastic)
astrocytoma with lesion visible on CT or MR and minimum histological grade of III/IV;

- Subject with suspect radiation necrosis that are planned for re-section;

- Subject or subject's legally acceptable representative provides informed consent;

- Subject is capable of complying with study procedures and able to lie still in the
PET scanner;

- Subject is capable of communicating with study personnel;

- Subject has adequate liver and kidney function

Exclusion Criteria:

- Subject is pregnant or nursing;

- Subject is anemic (as defined as a hemoglobin level <10);

- Subject has not received chemotherapy or radiation therapy within the two weeks prior
to imaging.

- Subject has as reflected by a serum liver enzymes outside the normal laboratory
reference range;

- Subject has a history of chronic liver disease, which may compromise liver function;

- Subject has kidney disease as reflected by a serum creatinine outside the normal
laboratory reference range;

- Subject has prior history of stroke or other condition of the head or neck that, in
the investigator's opinion, might affect circulation to the brain or image
interpretation (examples include, but are not limited to, previous stroke with cystic
softening and cerebral deformity, or arteriovenous malformation);

- Subject has a history of significant cerebrovascular disease;

- Subject has any other condition or personal circumstance that, in the judgment of the
investigator, might interfere with the collection of complete good quality data

- Subject has previously received [F-18]FLT at any time, or any other investigational
product within the past two weeks.

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Safety will be demonstrated through analysis of adverse events in subjects enrolled in the trial who received study drug

Outcome Time Frame:

24 hr

Safety Issue:


Principal Investigator

Charles M Intenzo, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Thomas Jefferson University Hospital, 132 S 10th St Phila, PA 19107


United States: Food and Drug Administration

Study ID:




Start Date:

November 2007

Completion Date:

May 2008

Related Keywords:

  • Brain Cancer
  • Brain Neoplasms



Thomas Jefferson University Hospital Philadelphia, Pennsylvania  19131