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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 is a Phase 1 study that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 12 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04105543
The ClinicalTrials.gov registry entry for NCT04105543 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Wisconsin, Madison, which has 1,039 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which CLR 131 is the first listed.
NCT04105543 reports 0 study locations.
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.
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