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

This study has been completed.
Sponsor:
Information provided by:
Siemens Molecular Imaging
ClinicalTrials.gov Identifier:
NCT00553748
First received: November 2, 2007
Last updated: July 1, 2008
Last verified: July 2008
  Purpose

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.


Condition Intervention Phase
Brain Cancer
Drug: F-18 FLT
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Phase I, Open Label, Single Center Safety Study of [F-18]FLT

Resource links provided by NLM:


Further study details as provided by Siemens Molecular Imaging:

Primary Outcome Measures:
  • Safety will be demonstrated through analysis of adverse events in subjects enrolled in the trial who received study drug [ Time Frame: 24 hr ] [ Designated as safety issue: Yes ]

Enrollment: 11
Study Start Date: November 2007
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 18-F FLT; [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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00553748

Locations
United States, Pennsylvania
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Siemens Molecular Imaging
Investigators
Principal Investigator: Charles M Intenzo, MD Thomas Jefferson University Hospital, 132 S 10th St Phila, PA 19107
  More Information

No publications provided

Responsible Party: Charles Intenzo, MD, Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT00553748     History of Changes
Other Study ID Numbers: D0008186
Study First Received: November 2, 2007
Last Updated: July 1, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Brain Neoplasms
Brain Diseases
Central Nervous System Diseases
Central Nervous System Neoplasms
Neoplasms
Neoplasms by Site
Nervous System Diseases
Nervous System Neoplasms

ClinicalTrials.gov processed this record on October 23, 2014