The primary study objective is to determine if microdoses of ABY-029 lead to detectable signals in sampled tissues with an EGFR pathology score ≥ 1 based on histological staining. The secondary study objective is to assess diagnostic accuracy of ABY-029 detection by iFI and intraoperative probe relative to histopathology diagnosis, and other indicators (e.g. proliferation, infiltration, etc.) as the gold standard, and to measure the molecular uptake and concentration of ABY-029 in resected specimens.
The investigators plan a sample size of 6-12 patients in this open label, single center, clinical trial of ABY-029. Administration will occur as a single intravenous injection to subjects with recurrent glioma, approximately 1-3 hours prior to surgery. The protocol is not a safety study since no physiological effects are expected at microdose levels of ABY-029. Rather, doses have been selected to determine if a fluorescence signal can be detected by wide-field imaging technology with a signal-to-noise ratio of 10, which is considered necessary for subsequent assessment of diagnostic performance of ABY-029 as a tumor biomarker sufficient to guide surgical resection in the future. No diagnostic or therapeutic intent is proposed, and administration of the study drug is not intended to alter the extent of planned brain tumor resection during the surgical procedure.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
14
Using a sample size of 6-12 patients, ABY-029 will be administered via single intravenous injection to subjects with recurrent glioma, approximately 1-3 hours prior to surgery. Microdose levels of ABY-029 have been selected to determine if a fluorescence signal can be detected by wide-field imaging technology with a signal-to-noise ratio of 10, which is considered necessary for subsequent assessment of diagnostic performance of ABY-029 as a tumor biomarker sufficient to guide surgical resection in the future. Administration of the study drug is not intended to alter the extent of planned brain tumor resection during the surgical procedure.
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Fluorescence Signal Detection
The primary study endpoint is to determine if the fluorescence signal from ABY-029, as measured by Biological Variance Ratio (BVR), can be detected in brain tissue during surgery. This will help researchers determine if ABY-029 functions well for imaging brain tumor tissue during surgery.
Time frame: during procedure
Mean Tumor-to-background Ratio
A secondary study endpoint is to calculate the ratio of the average (mean) fluorescence intensity of ABY-029 measured in the tumor, to the average (mean) fluorescence intensity of ABY-029 measured in the surrounding tissues in the brain during surgery. This will help researchers determine how well ABY-029 works for imaging tumor tissue.
Time frame: during procedure
Ex Vivo Fluorescence Intensity
Another secondary study endpoint is to quantify the relationship between the dose of ABY-029 administered and the fluorescence intensity produced by ABY-029 in ex vivo tissue samples after they have been transferred to the pathology department. This endpoint will be measured in relative fluorescence units, and will help researchers conduct analyses on how well ABY-029 works for imaging in tissue following surgery.
Time frame: post surgical
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