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A Microdose Evaluation Study of ABY-029 in Head and Neck Oncology Surgery

NCT03282461 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2023-05-18

No results posted yet for this study

Summary

The primary study objective is to determine if microdoses of ABY-029 (up to 6X) lead to detectable signals (defined as signal-to-noise ratio, SNR ≥10, with wide-field iFI) in sampled tissues with an EGFR (epidermal growth factor receptor) pathology score ≥ 1 based on histological staining.

The secondary study objective is to assess ex vivo the specificity of tumor binding in resected specimens by measuring the corresponding molecular uptake and concentrations using histopathology.

Conditions

Interventions

DRUG

ABY-029

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 operable head and neck cancer approximately 1-3 hours prior to surgery.

Sponsors & Collaborators

  • Dartmouth College

    collaborator OTHER

  • Dartmouth-Hitchcock Medical Center

    lead OTHER

Principal Investigators

  • Joseph A Paydarfar, MD · Dartmouth-Hitchcock Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-24
Primary Completion
2020-12-18
Completion
2020-12-18
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03282461 on ClinicalTrials.gov