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This research study is studying a drug called Demeclocycline that may help brain surgeons see tumors with a microscope during surgery.
Full description
This research study is a Feasibility Study, which is the first time investigators are examining this study intervention.The FDA (the U.S. Food and Drug Administration) has not approved Demeclocycline for your specific disease but it has been approved for other uses.
In this research study, the investigators would like to determine the lowest dose of Demeclocycline that will allow surgeons to detect tumor cells during surgery. These cells will be marked through a process called fluorescence, which will cause tumor cells to glow brightly on an image in comparison to its surroundings.
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Inclusion criteria
Participants must present with a gadolinium-enhancing brain lesion (or lesions) that are thought by the neuroradiologist and the neurosurgeon to be consistent with high-grade glioma. These may be newly diagnosed lesions or recurrent tumors.
The patient must not be pregnant or nursing. Tetracycline (Demeclocycline, Doxycycline, Minocycline, Tetracycline, and Tigecycline) are classified as FDA pregnancy category D. Maternal ingestion of Tetracyclines during pregnancy may cause tooth discoloration, enamel defects, and other congenital anomalies. Tetracyclines are excreted in human breast milk; however, the extent of absorption of Tetracyclines by the breastfed infant is not known.
Participants must have normal organ and marrow function as defined below:
Ability to understand and the willingness to sign a written informed consent document.
Participants must be undergoing a surgical procedure with the intention of removing more tissue than what would be taken for a biopsy.
Exclusion criteria
Primary purpose
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Interventional model
Masking
40 participants in 1 patient group
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Central trial contact
William T Curry, MD
Data sourced from clinicaltrials.gov
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