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NCT03282461 · ClinicalTrials.gov registry record · Early Phase 1
A Microdose Evaluation Study of ABY-029 in Head and Neck Oncology Surgery
A Early Phase 1 study, sponsored by Dartmouth-Hitchcock Medical Center.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 12
- Enrollment target
NCT03282461: Completed Early Phase 1 study, sponsored by Dartmouth-Hitchcock Medical Center.
NCT03282461 is a Early Phase 1 study 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). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03282461, a Early Phase 1 study, has completed, sponsored by Dartmouth-Hitchcock Medical Center.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 12 participants
- Enrollment target
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 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.
Primary Outcome
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.
Interventions
- DRUG ABY-029
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2018-01-24 |
| Est. Completion | 2020-12-18 |
| Phase | Early Phase 1 |
What the finished NCT03282461 record still lists
NCT03282461 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 0 conditions, and to 1 intervention - of which ABY-029 is the first listed.
NCT03282461 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03282461 about?
NCT03282461 is a clinical study titled "A Microdose Evaluation Study of ABY-029 in Head and Neck Oncology Surgery". 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 seco...
What is the current status of trial NCT03282461?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 12 participants. The study started on 2018-01-24. Estimated completion is 2020-12-18.
What interventions are being tested in trial NCT03282461?
The interventions under investigation include: ABY-029 (DRUG).
Who is sponsoring clinical trial NCT03282461?
This trial is sponsored by Dartmouth-Hitchcock Medical Center, which has 427 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03282461'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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