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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

November 2, 2007
July 1, 2008
November 2007
May 2008   (final data collection date for primary outcome measure)
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 ]
Safety will be demonstrated through analysis of adverse events in subjects enrolled in the trial who received study drug. [ Time Frame: 24 hour postdose ]
Complete list of historical versions of study NCT00553748 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Brain Cancer
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
Experimental: I
Intervention: Drug: F-18 FLT
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
11
May 2008
May 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00553748
D0008186
No
Charles Intenzo, MD, Thomas Jefferson University
Siemens Molecular Imaging
Not Provided
Principal Investigator: Charles M Intenzo, MD Thomas Jefferson University Hospital, 132 S 10th St Phila, PA 19107
Siemens Molecular Imaging
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP