Recruiting

LC-QSPECT Imaging

Sponsor:

Washington University School of Medicine

Code:

NCT07221825

Conditions

Prostate Cancer

Cancer of the Prostate

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Low-count quantitative single-photon emission computed tomography imaging

Study Details

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

Prostate Cancer

Cancer of the Prostate

Study ID

NCT07221825

Start date

Sep 1, 2026

Status verified date

Jul, 2026

Completion date

Jul 31, 2028

Anticipated

Primary completion date

Apr 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria - Patients:

  • 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.

Exclusion Criteria - Patients:

  • 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.

Study Design

Enrollment

38 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: LC-QSPECT

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.

no intervention: Physicians

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

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

Primary outcome measure

  • Spearman's correlation coefficient between the LC-QSPECT estimated uptake in the lesions and intestine with ex vivo activity sampling [ Time Frame: Through collection of ex vivo sample (estimated to be 3 months) ]

Central Contacts and Locations

Central contacts

Abhinav K Jha, Ph.D.

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

Locations

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Abhinav K Jha, Ph.D.

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

Principal Investigator:

Abhinav K Jha, Ph.D.

More Information

Sponsor

Washington University School of Medicine

Last update posted

Jul 21, 2026

Last verified

Jul, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-07-21.