ABY-029 for High-Grade Glioma Surgery
This study is testing a drug called ABY-029 in people with high-grade glioma (a type of brain tumor). The main goals are to see if ABY-029 is safe and to figure out the best amount to use so surgeons can see the tumor more clearly during surgery. You would receive ABY-029 through an IV right before your planned tumor removal surgery. Researchers will then use a special imaging system during surgery to measure the drug in your tumor and surrounding tissue. The study is looking for 33 participants aged 18 or older who have a high-grade glioma suitable for surgery and are able to give informed consent. The study status is currently unclear.
- Study design
- This is an interventional study planning to enroll 33 participants. It compares two groups receiving different, very small amounts of ABY-029.
- What's involved
- You would receive ABY-029 via IV injection 1-3 hours before surgery. All research procedures, including image and measurement data collection and biopsy sampling, occur during surgery.
- Compensation
- Not stated in the trial record.
- Follow-up
- Researchers will monitor for adverse events related to ABY-029 for one month. They will also assess the false negative rate of ABY-029 fluorescence for up to three months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
ABY-029 Glioma Trial
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Linton Evans, MD · PRINCIPAL_INVESTIGATOR · Dartmouth-Hitchcock Medical Center
Who to contact
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What this trial measures
- Adverse events related to ABY-029One month
To study the safety of ABY-029, adverse events related to 6X and 10X doses of ABY-029 will be tracked following surgery, and the proportion of study-drug related adverse events at 6X and 10X doses will be compared statistically for significant differences.
- False negative rate of ABY-029 fluorescenceUp to three months
To measure of diagnostic performance of ABY-029, the false negative rate of ABY-029 fluorescence measured during surgery in tissue samples that are confirmed to be tumor through pathology.