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NCT07217028 · ClinicalTrials.gov registry record · Phase 1
Study Evaluating [18F]NOTA-ABY030 for Safety and Tolerability of Indeterminate Primary and/or Metastatic Disease in Head and Neck Squamous Cell Carcinoma
A Phase 1 study, sponsored by Vanderbilt-Ingram Cancer Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
NCT07217028 is a Phase 1 study that is actively recruiting participants, run by Vanderbilt-Ingram Cancer Center. The registered enrollment target is 25 participants.
The verdict
NCT07217028, a Phase 1 study, is actively recruiting participants, sponsored by Vanderbilt-Ingram Cancer Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
Study Summary
This Phase I, single-institution, open-label study will evaluate the safety, tolerability, and diagnostic performance of \[18F\]NOTA-ABY030 PET/CT in patients with head and neck squamous cell carcinoma (HNSCC) who present with indeterminate lesions on standard imaging. The investigational agent is a radiolabeled anti-EGFR affibody designed for rapid clearance and improved tumor-to-background contrast. All participants will receive a 50 mg cetuximab loading dose followed by a bolus of \[18F\]NOTA-ABY030, with PET/CT imaging performed at defined intervals to assess biodistribution and lesion uptake. The primary objective is to determine safety and tolerability; secondary objectives include radiation dosimetry and comparison of sensitivity and specificity to conventional imaging modalities (MRI, CT, and \[18F\]FDG-PET/CT). This approach aims to improve diagnostic accuracy, reduce unnecessary biopsies, and streamline treatment decisions for patients with HNSCC.
Interventions
- PROCEDURE Positron Emission Tomography (PET)
- DRUG Cetuximab (EGFR inhibitor)
- DRUG 18F-NOTA-ABY-030
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2026-04-24 |
| Est. Completion | 2030-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07217028
The ClinicalTrials.gov registry entry for NCT07217028 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt-Ingram Cancer Center, which has 189 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Positron Emission Tomography (PET) is the first listed.
NCT07217028 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07217028 about?
NCT07217028 is a clinical study titled "Study Evaluating [18F]NOTA-ABY030 for Safety and Tolerability of Indeterminate Primary and/or Metastatic Disease in Head and Neck Squamous Cell Carcinoma". This Phase I, single-institution, open-label study will evaluate the safety, tolerability, and diagnostic performance of \[18F\]NOTA-ABY030 PET/CT in patients with head and neck squamous cell carcinoma (HNSCC) who present with indeterminate lesions on standard imaging. The investigational agent is a...
What is the current status of trial NCT07217028?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2026-04-24. Estimated completion is 2030-09.
What interventions are being tested in trial NCT07217028?
The interventions under investigation include: Positron Emission Tomography (PET) (PROCEDURE), Cetuximab (EGFR inhibitor) (DRUG), 18F-NOTA-ABY-030 (DRUG).
Who is sponsoring clinical trial NCT07217028?
This trial is sponsored by Vanderbilt-Ingram Cancer Center, which has 189 total clinical trials registered on ClinicalTrials.gov.
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