A Microdose Evaluation Study of ABY-029 in Recurrent Glioma

• Status: Completed
• Trial end date: 2021-06-29
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dartmouth-Hitchcock Medical Center
• Collaborator: Dartmouth College

Criteria

Inclusion Criteria:

1. Preoperative diagnosis of recurrent high-grade glioma having EGFR positive tissue from prior surgery.

2. Tumor judged to be suitable for open cranial resection based on preoperative imaging studies.

3. Valid informed consent by subject.

4. Age ≥ 18 years old.

Exclusion Criteria:

1. Pregnant women or women who are breast feeding.

2. Patients on any experimental anti-EGFR targeted therapies