Head and Neck Cancer Clinical Trial
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 Operable Head and Neck Cancer.
Verified date | May 2023 |
Source | Dartmouth-Hitchcock Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 12 |
Est. completion date | December 18, 2020 |
Est. primary completion date | December 18, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Preoperative diagnosis of head and neck cancer. 2. Tumor judged to be operable based on preoperative imaging studies. 3. Valid informed consent by subject or subject's Legally Authorized Representative. 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, either investigational or FDA approved. |
Country | Name | City | State |
---|---|---|---|
United States | Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire |
Lead Sponsor | Collaborator |
---|---|
Dartmouth-Hitchcock Medical Center | Dartmouth College |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Signal detection | For each pathology, predictive models of the odds of tumor positivity for biopsies given concentration of ABY-029 will be constructed. Histologically confirmed tumor status from biopsies will be statistically analyzed against the predictive models. The quantitative fluorescence measures will also be assessed for their fit with statistics. The predictive accuracy of the model fit will be summarized through an index. | Day of surgery, up to 1 week after surgery | |
Secondary | Correlation of spatial patterns of EGFR expression | Regions within the wide-field FI images will be classified as tumor on the basis of their fluorescence signals. Continuous, quantitative optical response data will also be available from the intraoperative probe recordings within the fields-of-view. Two-way classification tables will be examined for agreement between the methods for the "tumor" and "not tumor" categories from an individual patient. Statistical analysis will be used to determine if there is agreement with the region classifications. In a second analysis, histopathology from biopsies taken at FI-positive and negative sites will be classified as non-tumor tissue, solid tumor, infiltrating tumor, or indeterminate. The positive predictive values of these locations within the wide-field images will be calculated for each individual. These data will also be analyzed for sensitivity and specificity of the fluorescence image signatures relative to the reference standard (histopathology). |
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