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NCT03129061 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate Immunological Response to PD-1 Inhibition in Squamous Cell Carcinoma of the Head and Neck (SCCHN)
A Phase 1 study, sponsored by CellSight Technologies.
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT03129061: Completed Phase 1 study, sponsored by CellSight Technologies.
NCT03129061 is a Phase 1 study that has completed, run by CellSight Technologies. The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03129061, a Phase 1 study, has completed, sponsored by CellSight Technologies.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
This is a single-center cross-sectional imaging and correlative biomarker study in patients with Squamous Cell Carcinoma of the Head and Neck (SCCHN). Cohort 1 will be patients with unresectable or metastatic SCCHN cancer receiving standard of care (SOC) anti-PD-1 treatment and Cohort 2 will be neoadjuvant study participants who will receive one dose of anti-PD-1 treatment prior to tumor resection or radiation. Blood sampling and tissue biopsies will be collected from both cohorts and both cohorts will undergo two whole body PET(Positron Emission Tomography)/CT(Computed Tomography) imaging with \[18F\]F-AraG. First scan prior to initiating anti-PD-1 treatment and second scan post initiation of anti-PD-1 treatment in Cohort 1 and prior to tumor resection or radiation in Cohort 2
Primary Outcome
Assess whether \[18F\]F-AraG accumulation at the site of inflammation can be used for noninvasive imaging and assessment of T cell activation and expansion in the tumor microenvironment. Specifically, we will be assessing if there is a correlation between an increase in the imaging signal and an increase in T cell activation (measured directly from the T cells obtained from biopsy specimens).
Interventions
- DRUG [18F]F-AraG PET Scan, baseline + post anti-PD-1 therapy.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2017-05-01 |
| Est. Completion | 2022-12-01 |
| Phase | Phase 1 |
What the finished NCT03129061 record still lists
NCT03129061 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 1 intervention - of which [18F]F-AraG PET Scan, baseline + post anti-PD-1 therapy. is the first listed.
NCT03129061 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03129061 about?
NCT03129061 is a clinical study titled "Study to Evaluate Immunological Response to PD-1 Inhibition in Squamous Cell Carcinoma of the Head and Neck (SCCHN)". This is a single-center cross-sectional imaging and correlative biomarker study in patients with Squamous Cell Carcinoma of the Head and Neck (SCCHN). Cohort 1 will be patients with unresectable or metastatic SCCHN cancer receiving standard of care (SOC) anti-PD-1 treatment and Cohort 2 will be neoa...
What is the current status of trial NCT03129061?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2017-05-01. Estimated completion is 2022-12-01.
What interventions are being tested in trial NCT03129061?
The interventions under investigation include: [18F]F-AraG PET Scan, baseline + post anti-PD-1 therapy. (DRUG).
Who is sponsoring clinical trial NCT03129061?
This trial is sponsored by CellSight Technologies, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03129061's enrollment target sits among peer trials
15 1798th of 2000 higher than 157 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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