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

NCT07221825 | Not Yet Recruiting DMC FDA Device

• 2 other identifiers: 202506234R01EB031962
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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

Cancer of the Prostate; Prostate Cancer

Keywords

Prostate cancer; Bone metastasis; SPECT; Radiopharmaceutical therapies; Theranostics; Alpha-particle; Xofigo

Outcome Measures

Primary Outcomes (1)

• Spearman's correlation coefficient between the LC-QSPECT estimated uptake in the lesions and intestine with ex vivo activity sampling

  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.

  Through collection of ex vivo sample (estimated to be 3 months)

Secondary Outcomes (12)

• LC-QSPECT related adverse events

  From start of LC-QSPECT imaging through 12 hours following LC-QSPECT imaging

• Percentage of enrolled patients who withdraw from the study due to adverse events at least possibly related to LC-QSPECT (as chosen by patients or treating physician team)

  From start of LC-QSPECT imaging through 12 hours following LC-QSPECT imaging

• Feasibility of conducting LC-QSPECT will be determined by percentage of SPECT scans that can be processed using the investigators' computational method

  Through completion of LC-QSPECT imaging (estimated to be 3 months)

• Correlation between the LC-QSPECT measurements and PSA (Spearman Correlation Coefficient)

  Through completion of Xofigo treatment (estimated to be 6 months)

• Correlation between the LC-QSPECT measurements and PSA doubling time (Spearman Correlation Coefficient)

  Through completion of Xofigo treatment (estimated to be 6 months)

Study Arms (2)

LC-QSPECT

EXPERIMENTAL

Consenting and eligible men receiving standard of care (Xofigo) will receive a noninvasive LC-QSPECT scan (\~45 minutes) and a low-dose contrast-enhanced CT after Cycles 1 and 3 of Xofigo. SOC CT and bone scans will also be performed at baseline and after Cycles 3 and 6. Specimen collection will be as follows: bone biopsy (Cycle 1 Day 2) (optional), stool (first bowel movement post-each SPECT scan), and blood for PSA and bone turnover biomarkers (with each cycle of treatment). Additionally, pain will be assessed, and quality of life will be monitored prior to treatment and after each treatment cycle.

Device: Low-count quantitative single-photon emission computed tomography imaging

Physicians

NO INTERVENTION

Additionally, medical oncologists and radiation oncologists who are seeing patients who are enrolled in this study will be considered participants in this study (as they will be completing the Physician Questionnaire).

Interventions

Low-count quantitative single-photon emission computed tomography imaging DEVICE

LC-QSPECT scans will be performed between 6 and 36 hours after administration of Xofigo during Cycles 1 and 3.

Also known as: LC-QSPECT

LC-QSPECT

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Predominant visceral metastatic disease.
• 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
• Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
• Concurrent alternative radiopharmaceuticals
• Inability to maintain stationary supine pose for 45-60 minutes
• Eligibility Criteria - Physicians:
• Medical Oncologist or Radiation Oncologist at Siteman Cancer Center.
• Treating patients with prostate cancer.
• Willing to complete Physician Questionnaire during participation.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Institute for Biomedical Imaging and Bioengineering (NIBIB): collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Abhinav K Jha, Ph.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abhinav K Jha, Ph.D.

CONTACT

314-273-2655; a.jha@wustl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2025
• First Posted: October 28, 2025
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 12 months after publication of primary results; available for at least 5 years.
• Access Criteria: Data will be shared through a controlled-access repository. Access will require a brief proposal and a signed data use agreement.

Locations

US (1)