Status:
COMPLETED
[F-18] Fluorothymidine (FLT) Imaging on Patients With Primary Brain Tumors
Lead Sponsor:
University of Utah
Conditions:
Cancer
Brain Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Despite significant advances in the understanding of brain tumor biology and genetics as well as improvements in surgical techniques, radiotherapy administration, and chemotherapy methods, many primar...
Detailed Description
The primary objective of this study is to assess the preliminary efficacy of the radiopharmaceutical 3'-deoxy-3'-\[F-18\]fluorothymidine, \[F-18\]FLT, a radiopharmaceutical that directly assess tumor ...
Eligibility Criteria
Inclusion
- Adult patients (n = 20) with primary brain tumors will be studied.
- All patients will have had previous radiation and may or may not have had chemotherapy for treatment of the primary brain tumor.
- All patients must have either radiological or established histological diagnosis of the following general categories: glioma (grade 2 to grade 4) previously treated with radiation therapy and possibly chemotherapy. It is expected that some of the patients may need a biopsy or neurosurgical procedure for diagnostic and/or therapeutic purposes as necessary treatment of their disease. In those instances the pathologic results will be used for correlation with the imaging findings. Only clinically indicated biopsy and/or surgery will be done and surgery is incidental to inclusion in the protocol.
- Patients must be 18 years or older for inclusion in this study.
- After entry into the study, the initial 12 patients are expected to be followed for at least 1 month after the infusion of \[F-18\]FLT.
- The patient, if female, must be postmenopausal for a minimum of one year or surgically sterile, or on one of the following methods of birth control for a minimum of one month prior to entry into this study: IUD, oral contraceptives, Depo-Provera or Norplant. These criteria can be waived at the discretion of the investigator if the patient's intracranial tumor is considered life threatening and the one month wait required is not in the best interest of the patient. Negative pregnancy test is accepted.
- Pre-treatment laboratory tests for patients receiving \[F-18\]FLT must be performed within 14 days prior to study entry. These must no greater or less than 4X the normal upper or lower limits. These will include liver enzymes (SGOT, SGPT, ALK Phos, GGT, LDH), bilirubin (direct and total), amylase, serum electrolytes, CBC with platelets and absolute neutrophil counts, prothrombin time, partial thromboplastin time, BUN, creatinine, and urinalysis.
- Pre-treatment radiological scans/studies (Gd- enhanced MRI and FDG-PET) for patients receiving \[F-18\]FLT must be performed within 10 days of study entry.
Exclusion
- Patients with clinically significant signs of uncal herniation, such as acute pupillary enlargement, rapidly developing motor changes (over hours), or rapidly decreasing level of consciousness, are not eligible.
- Patients with known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals. Patients with significant drug or other allergies or autoimmune diseases may be enrolled at the Investigator's discretion.
- Patients who are pregnant or lactating or who suspect they might be pregnant.
- Adult patients who require monitored anesthesia for PET scanning.
- HIV positive patients due to the previous toxicity noted with FLT in this patient group.
Key Trial Info
Start Date :
October 31 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2010
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00707343
Start Date
October 31 2007
End Date
November 30 2010
Last Update
October 15 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112