NCT07221825

Low-Count Quantitative SPECT for Men Treated With Radium-223

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (estimated)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer
• Cancer of the Prostate

Interventions

Type	Name	Description
DEVICE	Low-count quantitative single-photon emission computed tomography imaging	LC-QSPECT scans will be performed between 6 and 36 hours after administration of Xofigo during Cycles 1 and 3.

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-12-31
• Completion: 2028-03-31
• First posted: 2025-10-28
• Last updated: 2026-01-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study