Phase I, Open Label, Single Center Safety Study of [F-18]FLT
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ClinicalTrials.gov Identifier: NCT00553748 |
Recruitment Status :
Completed
First Posted : November 6, 2007
Last Update Posted : July 3, 2008
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Brain Cancer | Drug: F-18 FLT | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 11 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | A Phase I, Open Label, Single Center Safety Study of [F-18]FLT |
Study Start Date : | November 2007 |
Actual Primary Completion Date : | May 2008 |
Actual Study Completion Date : | May 2008 |
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 Name: 18-F FLT; [F-18]FLT |
- Safety will be demonstrated through analysis of adverse events in subjects enrolled in the trial who received study drug [ Time Frame: 24 hr ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00553748
United States, Pennsylvania | |
Thomas Jefferson University Hospital | |
Philadelphia, Pennsylvania, United States, 19107 |
Principal Investigator: | Charles M Intenzo, MD | Thomas Jefferson University Hospital, 132 S 10th St Phila, PA 19107 |
Responsible Party: | Charles Intenzo, MD, Thomas Jefferson University |
ClinicalTrials.gov Identifier: | NCT00553748 |
Other Study ID Numbers: |
D0008186 |
First Posted: | November 6, 2007 Key Record Dates |
Last Update Posted: | July 3, 2008 |
Last Verified: | July 2008 |
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