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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: Completed Early Phase 1 study of Primary Soft-tissue Sarcoma, sponsored by Dartmouth-Hitchcock Medical Center.
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, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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.
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 |
What the finished NCT03154411 record still lists
NCT03154411 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (77% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03154411's enrollment target sits among peer trials
12 1530th of 2000 higher than 401 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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