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

NCT00553748 | Completed Phase 1

• 1 other identifier: D0008186
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Brain Cancer

Outcome Measures

Primary Outcomes (1)

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

  24 hr

Study Arms (1)

I

EXPERIMENTAL

Drug: F-18 FLT

Interventions

F-18 FLT DRUG

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.

Also known as: 18-F FLT; [F-18]FLT

I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Siemens Molecular Imaging: lead

Study Sites (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Brain Neoplasms

Interventions

alovudine

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Charles M Intenzo, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 2, 2007
• First Posted: November 6, 2007
• Study Start: November 1, 2007
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: July 3, 2008

Record last verified: 2008-07

Locations

US (1)