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