Status:

COMPLETED

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

Lead Sponsor:

Dartmouth-Hitchcock Medical Center

Collaborating Sponsors:

Dartmouth College

Conditions:

Head and Neck Cancer

Eligibility:

All Genders

18+ years

Phase:

EARLY_PHASE1

Brief 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 E...

Detailed Description

The investigators plan to enroll a minimum of 6 and a maximum of 12 adult patients with a diagnosis of operable head and neck cancer in this open label, single center, clinical trial of ABY-029. Admi...

Eligibility Criteria

Inclusion

  • Preoperative diagnosis of head and neck cancer.
  • Tumor judged to be operable based on preoperative imaging studies.
  • Valid informed consent by subject or subject's Legally Authorized Representative.
  • Age ≥ 18 years old.

Exclusion

  • Pregnant women or women who are breast feeding.
  • Patients on any experimental anti-EGFR targeted therapies, either investigational or FDA approved.

Key Trial Info

Start Date :

January 24 2018

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 18 2020

Estimated Enrollment :

12 Patients enrolled

Trial Details

Trial ID

NCT03282461

Start Date

January 24 2018

End Date

December 18 2020

Last Update

May 18 2023

Active Locations (1)

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1

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States, 03756