NCT07221825Recruiting
Low-Count Quantitative SPECT for Men Treated With Radium-223
Source: ClinicalTrials.gov · Last updated 15 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 38 (estimated)
- First submitted
- 25 Oct 2025
- Start date
- 1 Nov 2026
- Primary completion date
- 30 Apr 2028
- Lead sponsor
- Washington University School of Medicine
- Diseases
- Prostate cancer
- NCT number
- NCT07221825
What you commit to
- Study type: Interventional
- Planned participants: 38
- From 1 Nov 2026 to the primary completion date, 30 Apr 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for this trial
- Concurrent alternative radiopharmaceuticals
Other illness
- Predominant visceral metastatic disease.
- Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
- Medical Oncologist or Radiation Oncologist at Siteman Cancer Center.
- Treating patients with prostate cancer.
Other
- Inability to maintain stationary supine pose for 45-60 minutes
- Eligibility Criteria - Physicians:
- Willing to complete Physician Questionnaire during participation.
Who the study is looking for
- Histologically or cytologically confirmed castration-resistant prostate cancer with symptomatic bone metastases.
- Minimum detectable skeletal lesion count of 3.
- Eligible to receive Xofigo.
- At least 18 years of age.
- ECOG performance status ≤ 3.
- Ability to understand and willingness to sign an IRB-approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Washington University School of Medicine Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.