Primary Soft-tissue Sarcoma 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 Primary Sarcoma.
| Verified date | August 2021 |
| 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 the Odyssey NIR scanner in sampled tissues with an EGFR pathology score ≥ 1 based on histological staining and compare SNR to tissues with an EGFR pathology score < 1). The secondary study objective is to assess if the spatial patterns of EGFR expression correlate with the tumor targeting of ABY-029 detection by NIR scanner relative to histopathology diagnosis, and other indicators (e.g. proliferation, infiltration, etc.) as the gold standard, and to measure the molecular uptake and concentration of ABY-029 in resected specimens.
| Status | Completed |
| Enrollment | 12 |
| Est. completion date | December 10, 2020 |
| Est. primary completion date | December 10, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: 1. Preoperative histological diagnosis of primary sarcoma. 2. Tumor judged to be suitable for open surgical resection based on preoperative imaging studies. 3. Valid informed consent by subject. 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 | Following tumor excision, the tumor will be inked and sectioned and imaged using a near-infrared scanner and fiber-probe based system. Quantitative measurements of fluorophore concentration will be measured for tumors with EGFR pathology score = 1 and compared to those with EGFR pathology score < 1. | Day of surgery, up to 1 week after surgery | |
| Secondary | Correlation of spatial patterns of EGFR expression | Quantitative mapping of fluorophore concentration will be correlated with local EGFR concentration and blood vessel density. | within 1 week of surgery | |
| Secondary | molecular uptake and ABY-029 concentration | Fluorophore measurements will be taken from normal, marginal tissues (e.g. skeletal muscle, adipose) in addition to the tumor. Average EGFR concentration and blood vessel density will be determined for each tumor through histological analysis of sections by routine sarcoma protocol and analysis guided by regional variations in ABY-029 concentration based upon near-infrared scan results. | within 1 week of surgery |