ABY-029 Glioma Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ABY-029.
- Who it may be relevant to
- Registry conditions: Intracranial Tumor. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Phase 1 Trial of ABY-029 Fluorescence in Patients With High-Grade Glioma
Overview
The purposes of the research trial are to study the safety of ABY-029 and to understand how much of the drug is needed to reach brain tumors so it can be visualized best by surgeons. Investigators will do this by comparing two groups of participants that receive different, very small amounts of ABY-029. Investigators will use an imaging system during surgery to record the amount of ABY-029 in the participant's tumor and in the surrounding tissue.
Interventions
- Drug ABY-029
ABY-029 will be administered via single intravenous injection to subjects with high-grade glioma approximately 1-3 hours prior to surgery. All research procedures will occur during surgery. The research procedures involve image and measurement data collection and biopsy specimen sampling. Research data collection will occur at 3 or 4 time points during surgery using either standard-of-care tools and methods or non-significant risk experimental devices. No follow-up visit will be required of pa
Primary outcome measures
- Adverse events related to ABY-029 [Time frame: One month]
- False negative rate of ABY-029 fluorescence [Time frame: Up to three months]
Eligibility criteria
Inclusion criteria
- Clinical diagnosis of presumed high-grade glioma, based on image data.
- Tumor judged to be suitable and planned for open cranial resection.
- Valid informed consent by participant.
- Age ≥ 18 years old.
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
- Prisoners
- Individuals who are pregnant or breast feeding.
- Participants on any experimental or approved anti-EGFR targeted therapies
- Elevated kidney or liver function tests (levels greater than 2.5 times the normal limit) from laboratory tests conducted as part of standard-of-care screening of prospective surgical participants no earlier than 30 days prior to surgery.
- Any condition which, in the opinion of the clinical investigator, contraindicates research participation.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- Dartmouth-Hitchcock Medical Center — Lebanon
Identifiers
NCT: NCT07063693 · 02002497 · R01CA167413