Status:
TERMINATED
Assessment of Primary and Metastatic Brain Tumor Hypoxia With Fluoromisonidazole, FDG and Water
Lead Sponsor:
University of Utah
Conditions:
Brain Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Purpose of Study This exploratory clinical study will investigate FMISO (fluoromisonidazole) in patients with (1) newly diagnosed primary malignant brain tumors (WHO \[World Health Organization\] Grad...
Detailed Description
Malignant Brain Tumors (Primary and Metastatic) Despite significant advances in the understanding of brain tumor biology and genetics as well as improvements in surgical techniques, radiotherapy admin...
Eligibility Criteria
Inclusion
- Adult patients. The patient must have a newly diagnosed primary malignant brain tumors (WHO Grade III or IV glial-based tumors) and not have had a complete surgical resection and by contrast MRI (obtained within 14 days prior to the FMISO study)
- Patients must be 18 years or older for inclusion in this research study.
- Patients must document their willingness to be followed until death or time of progression.
- All patients must sign a written informed consent and HIPAA authorization in accordance with institutional guidelines.
- Female patients who are not postmenopausal or surgically sterile will undergo a serum pregnancy test prior to the research PET scans.
- Pre-treatment laboratory tests for patients receiving \[18F\]FMISO must be performed within 21 days prior to study entry.
Exclusion
- Patients with known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals.
- Patients who are pregnant or lactating or who suspect they might be pregnant.
- Adult patients who require monitored anesthesia for PET scanning.
- Patients who are too claustrophobic to undergo MRI or PET imaging
- Patients who cannot undergo MRI imaging due to MRI exclusion criteria
Key Trial Info
Start Date :
March 27 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 3 2014
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT01246869
Start Date
March 27 2013
End Date
May 3 2014
Last Update
October 1 2024
Active Locations (1)
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1
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112