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

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 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.

Study Overview

• Status: Completed
• Conditions: Brain Cancer
• Intervention / Treatment: Drug: F-18 FLT

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: I	Drug: F-18 FLT; One - 10 mci dose of F-18 FLT is administered IV over about 5 seconds prior to PET imaging. Each imaging dose contains no more than 6.1 micrograms of FLT.; Other Names: 18-F FLT; [F-18]FLT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety will be demonstrated through analysis of adverse events in subjects enrolled in the trial who received study drug	24 hr

Collaborators and Investigators

• Sponsor: Siemens Molecular Imaging
• Investigators: Principal Investigator: Charles M Intenzo, MD, Thomas Jefferson University Hospital, 132 S 10th St Phila, PA 19107

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Actual): May 1, 2008
• Study Completion (Actual): May 1, 2008

Study Registration Dates

• First Submitted: November 2, 2007
• First Submitted That Met QC Criteria: November 2, 2007
• First Posted (Estimate): November 6, 2007

Study Record Updates

• Last Update Posted (Estimate): July 3, 2008
• Last Update Submitted That Met QC Criteria: July 1, 2008
• Last Verified: July 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Neoplasms; Anti-Infective Agents; Antiviral Agents; Alovudine
• Other Study ID Numbers: D0008186