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NCT07221825 · ClinicalTrials.gov registry record · NA
Low-Count Quantitative SPECT for Men Treated With Radium-223
A NA study, sponsored by Washington University School of Medicine.
- Not yet
- Registry status
- NA
- Development phase
- 38
- Enrollment target
NCT07221825: Clinical Trial NA study, sponsored by Washington University School of Medicine.
NCT07221825 is a NA study that has not yet begun recruiting, run by Washington University School of Medicine. The registered enrollment target is 38 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07221825, a NA study, has not yet begun recruiting, sponsored by Washington University School of Medicine.
- NOT YET RECRUITING
- Registry status
- NA
- Development phase
- 38 participants
- Enrollment target
Study Summary
Internal radiotherapies (radiolabeled molecules that are systemically administered and localize to sites of disease) provide cancer-ablating doses to diseased cells while sparing adjacent normal tissues. \[223Ra\]RaCl2 (Xofigo) is the first FDA-approved alpha-particle emitting radiopharmaceutical therapy (αRPT), providing a survival benefit for men with bone metastatic castration-resistant prostate cancer. Systemically administered radiotherapies distribute throughout the patient, accumulating to unknown levels at sites of disease and in radiosensitive vital organs. The whole-body distribution means that absorbed doses in the patient extend far beyond a pre-defined treatment field. There is a lack of information about αRPT distribution and localization, and this confounds treatment monitoring, complicates dose and schedule personalization, and impedes drug development. Single-photon emission computed tomography (SPECT) imaging offers a mechanism to quantify uptake; however, αRPT administered activities are significantly lower than those used with diagnostic procedures, which presents a challenge for quantitation with conventional methods. Preliminary research shows that low-count quantitative SPECT (LC-QSPECT) imaging demonstrates reliable quantitation of regional uptake for αRPTs. The purpose of this study is to demonstrate the feasibility, tolerability and performance of LC-QSPECT imaging.
Primary Outcome
The investigators will assess if the correlation (in absolute magnitude) ≥ 0.60 between the tissue and SPECT data against a low correlation of \< 0.2 based on 1-sided normal test at a 5% level.
Interventions
- DEVICE Low-count quantitative single-photon emission computed tomography imaging
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2026-07-01 |
| Est. Completion | 2028-07-31 |
| Phase | NA |
What is known before NCT07221825 opens enrollment
NCT07221825 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Low-count quantitative single-photon emission computed tomography imaging is the first listed.
NCT07221825 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07221825 about?
NCT07221825 is a clinical study titled "Low-Count Quantitative SPECT for Men Treated With Radium-223". Internal radiotherapies (radiolabeled molecules that are systemically administered and localize to sites of disease) provide cancer-ablating doses to diseased cells while sparing adjacent normal tissues. \[223Ra\]RaCl2 (Xofigo) is the first FDA-approved alpha-particle emitting radiopharmaceutical th...
What is the current status of trial NCT07221825?
This trial is currently not yet recruiting. It is a NA study. The enrollment target is 38 participants. The study started on 2026-07-01. Estimated completion is 2028-07-31.
What interventions are being tested in trial NCT07221825?
The interventions under investigation include: Low-count quantitative single-photon emission computed tomography imaging (DEVICE).
Who is sponsoring clinical trial NCT07221825?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07221825's enrollment target sits among peer trials
38 1538th of 2000 higher than 461 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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