Intracranial Tumor
Conditions
Keywords
ABY-029, Affibody, Molecular Fluorescence-Guided Surgery, Epidermal Growth Factor Receptor (EGFR)
Brief summary
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
DRUGABY-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 participants. Participants will be monitored for possible adverse events for approximately 30 days by the operating surgeon involved in the clinical trial procedures and through review of participant medical records.
Sponsors
Dartmouth-Hitchcock Medical Center
Dartmouth College
National Cancer Institute (NCI)
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Sixteen participants with EGFR-positive tumors will be enrolled, alternating between two ABY-029 administration doses (the 6X dose and 10X dose), until eight participants with EGFR-positive tumors have been enrolled at each dose group. Because some participants may have EGFR-negative tumors, it may be necessary to enroll up to 33 participants before the target enrollment (eight participants with EGFR-positive tumors at each of two ABY-029 doses) is met.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Clinical diagnosis of presumed high-grade glioma, based on image data. 2. Tumor judged to be suitable and planned for open cranial resection. 3. Valid informed consent by participant. 4. Age ≥ 18 years old. 5. Ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
1. Prisoners 2. Individuals who are pregnant or breast feeding. 3. Participants on any experimental or approved anti-EGFR targeted therapies 4. 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. 5. Any condition which, in the opinion of the clinical investigator, contraindicates research participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events related to ABY-029 | One 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 fluorescence | Up 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. |
Countries
United States
Contacts
CONTACTKeith D Paulsen, PhD
CONTACTLinton Evans, MD
PRINCIPAL_INVESTIGATORLinton Evans, MD
Dartmouth-Hitchcock Medical Center
Outcome results
None listed