A Microdose Evaluation Study of ABY-029 in Recurrent Glioma

Glioma Clinical Trial

— ABY-029  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02901925
• Other study ID #: D16107
• Status: Completed
• Phase: Early Phase 1
• Start date: February 13, 2017
• Est. completion date: June 29, 2021

Study information

• Verified date: July 2021
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 29, 2021
• Est. primary completion date: June 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glioma

Intervention

Drug:
• ABY-029
Using a sample size of 6-12 patients, ABY-029 will be administered via single intravenous injection to subjects with recurrent glioma, approximately 1-3 hours prior to surgery. Microdose levels of ABY-029 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. Administration of the study drug is not intended to alter the extent of planned brain tumor resection during the surgical procedure.

Locations

Country	Name	City	State
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (2)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	Dartmouth College

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	signal detection	The primary study endpoint is signal detection (defined as Signal-to-Noise Ratio (SNR) with wide-field iFI) in vivo in brain tissues within the surgical field intended for resection that are subsequently sampled during surgery and assigned an EGFR pathology score based on histological staining.	during procedure
Secondary	diagnostic accuracy of ABY-029 detection	Diagnostic accuracy of ABY-029 detection will be measured by iFI and intraoperative probe relative to histopathology tissue diagnosis, and other indicators (e.g. proliferation, infiltration, etc.) as the gold standard.	during procedure
Secondary	molecular uptake	molecular uptake and concentration of ABY-029 will be measured in resected specimens.	during procedure