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NCT04105543 · ClinicalTrials.gov registry record · Phase 1
CLR 131 Combined With Radiation for Head and Neck Cancer
A Phase 1 study, sponsored by University of Wisconsin, Madison.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT04105543: Completed Phase 1 study, sponsored by University of Wisconsin, Madison.
NCT04105543 is a Phase 1 study that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04105543, a Phase 1 study, has completed, sponsored by University of Wisconsin, Madison.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
This is a Phase 1 study of the use of an investigational drug that selectively delivers radiation to malignant tumor cells, CLR 131, in combination with external beam radiation therapy (EBRT) in subjects with locoregionally recurrent head and neck cancer. The trial will enroll up to 12 participants who are amenable to retreatment with radiation therapy. Participants who also have distant metastatic disease may be enrolled on this clinical trial, but they must have evaluable disease that will be clinically treated with radiation therapy, as per standard of care. All participants will receive a dosimetry test dose of CLR 131 to establish drug uptake by the tumor and enable Monte Carlo dose estimation based on CLR 131 SPECT/CT imaging evaluation. Participants showing uptake will receive a cumulative tumor dose of 60-70 Gy using personalized dose calculation (via Monte Carlo methods) of CLR 131 combined with external beam radiation.
Primary Outcome
Incidence of adverse events assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Adverse Events Grading (1 = mild, 2 = moderate, 3 = severe, 4 = life threatening, and 5 = death)
Interventions
- DRUG CLR 131
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2019-12-20 |
| Est. Completion | 2024-02-01 |
| Phase | Phase 1 |
What the finished NCT04105543 record still lists
NCT04105543 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 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 1 intervention - of which CLR 131 is the first listed.
NCT04105543 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04105543 about?
NCT04105543 is a clinical study titled "CLR 131 Combined With Radiation for Head and Neck Cancer". This is a Phase 1 study of the use of an investigational drug that selectively delivers radiation to malignant tumor cells, CLR 131, in combination with external beam radiation therapy (EBRT) in subjects with locoregionally recurrent head and neck cancer. The trial will enroll up to 12 participants ...
What is the current status of trial NCT04105543?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2019-12-20. Estimated completion is 2024-02-01.
What interventions are being tested in trial NCT04105543?
The interventions under investigation include: CLR 131 (DRUG).
Who is sponsoring clinical trial NCT04105543?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04105543's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 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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