Back to resultsPhase I, Open Label, Single Center Safety Study of [F-18]FLT
Primary Purpose
Brain Cancer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
F-18 FLT
Sponsored by
About this trial
This is an interventional diagnostic trial for Brain Cancer
Eligibility 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.
Sites / Locations
- Thomas Jefferson University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
I
Arm Description
Outcomes
Primary Outcome Measures
Safety will be demonstrated through analysis of adverse events in subjects enrolled in the trial who received study drug
Secondary Outcome Measures
Full Information
NCT ID
NCT00553748
First Posted
November 2, 2007
Last Updated
July 1, 2008
Sponsor
Siemens Molecular Imaging
1. Study Identification
Unique Protocol Identification Number
NCT00553748
Brief Title
Phase I, Open Label, Single Center Safety Study of [F-18]FLT
Official Title
A Phase I, Open Label, Single Center Safety Study of [F-18]FLT
Study Type
Interventional
2. Study Status
Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Siemens Molecular Imaging
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
I
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
F-18 FLT
Other Intervention Name(s)
18-F FLT; [F-18]FLT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Safety will be demonstrated through analysis of adverse events in subjects enrolled in the trial who received study drug
Time Frame
24 hr
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles M Intenzo, MD
Organizational Affiliation
Thomas Jefferson University Hospital, 132 S 10th St Phila, PA 19107
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Phase I, Open Label, Single Center Safety Study of [F-18]FLT
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