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NCT03154411 · ClinicalTrials.gov registry record · Early Phase 1
A Microdose Evaluation Study of ABY-029 in Primary Sarcoma
A Early Phase 1 study of Primary Soft-tissue Sarcoma, sponsored by Dartmouth-Hitchcock Medical Center.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT03154411 is a Early Phase 1 study of Primary Soft-tissue Sarcoma that has completed, run by Dartmouth-Hitchcock Medical Center. The registered enrollment target is 12 participants. The trial reports 1 study location across 1 state.
The verdict
NCT03154411, a Early Phase 1 study of Primary Soft-tissue Sarcoma, has completed, sponsored by Dartmouth-Hitchcock Medical Center.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
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 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.
Conditions Studied
Interventions
- DRUG ABY-029
Study Locations (1)
New Hampshire
- Dartmouth-Hitchcock Medical Center - Lebanon
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2017-08-30 |
| Est. Completion | 2020-12-10 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03154411
The ClinicalTrials.gov registry entry for NCT03154411 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Dartmouth-Hitchcock Medical Center, which has 427 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Primary Soft-tissue Sarcoma appearing as the primary indexed condition, and to 1 intervention - of which ABY-029 is the first listed.
NCT03154411 reports 1 study location spanning 1 distinct geographic area - top geographies include New Hampshire.
Frequently Asked Questions
What is clinical trial NCT03154411 about?
NCT03154411 is a clinical study titled "A Microdose Evaluation Study of ABY-029 in Primary Sarcoma". 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 EG...
What is the current status of trial NCT03154411?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 12 participants. The study started on 2017-08-30. Estimated completion is 2020-12-10.
What conditions does trial NCT03154411 study?
This clinical trial studies the following conditions: Primary Soft-tissue Sarcoma.
What interventions are being tested in trial NCT03154411?
The interventions under investigation include: ABY-029 (DRUG).
Who is sponsoring clinical trial NCT03154411?
This trial is sponsored by Dartmouth-Hitchcock Medical Center, which has 427 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03154411 being conducted?
This trial has 1 study location across New Hampshire. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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