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

Completed · Phase 1

Conditions studied: Brain Cancer

In brief

This is a ten subject, phase 1 study. The purpose of the Phase 1 study is to demonstrate drug safety in a target group of subjects with high grade brain cancer. This population represents a potential clinical population that may benefit from this PET imaging tracer. The study will also begin collection of baseline imaging data and allow us to gain information to improve design and conduct of future trials.

Key facts

Study ID

NCT00553748

Run by

Siemens Molecular Imaging

People needed

11

Starts

2007-11-01

Expected to finish

2008-05-01

Last updated by the study team

2008-07-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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