A Microdose Evaluation Study of ABY-029 in Recurrent Glioma

EARLY_PHASE1CompletedINTERVENTIONAL
Enrollment

14

Participants

Timeline

Start Date

February 13, 2017

Primary Completion Date

June 29, 2021

Study Completion Date

June 29, 2021

Conditions
Glioma
Interventions
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.

Trial Locations (1)

03756

Dartmouth-Hitchcock Medical Center, Lebanon

All Listed Sponsors
collaborator

Dartmouth College

OTHER

collaborator

National Cancer Institute (NCI)

NIH

lead

Dartmouth-Hitchcock Medical Center

OTHER

NCT02901925 - A Microdose Evaluation Study of ABY-029 in Recurrent Glioma | Biotech Hunter | Biotech Hunter