A Microdose Evaluation Study of ABY-029 in Recurrent Glioma
| Status: | Recruiting |
|---|---|
| Conditions: | Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/27/2019 |
| Start Date: | December 2016 |
| End Date: | December 31, 2019 |
| Contact: | Keith D Paulsen, PhD |
| Email: | keith.d.paulsen@dartmouth.edu |
| Phone: | 603-646-2695 |
A Phase 0 Open Label, Single-center Clinical Trial of ABY-029, an Anti-EGFR Fluorescence Imaging Agent Via Single Intravenous Injection to Subjects With Recurrent Glioma
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.
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.
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.
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
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