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NCT Number: NCT07221825

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 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.

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Key information

Conditions

Prostate Cancer Cancer of the Prostate Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location status: Recruiting

Location contact

Abhinav K Jha, Ph.D.

CONTACT

[email protected]

314-273-2655

Abhinav K Jha, Ph.D.

PRINCIPAL_INVESTIGATOR

Daniel Thorek, Ph.D.

SUB_INVESTIGATOR

Hiram Gay, M.D.

SUB_INVESTIGATOR

Jingqin (Rosy) Luo, Ph.D.

SUB_INVESTIGATOR

Richard L Wahl, M.D.

SUB_INVESTIGATOR

Richard Laforest, Ph.D.

SUB_INVESTIGATOR

Tyler J Fraum, M.D.

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: LC-QSPECT

Primary outcomes

  1. 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)

    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.

Secondary outcomes

  1. LC-QSPECT related adverse events

    Time frame: From start of LC-QSPECT imaging through 12 hours following LC-QSPECT imaging

  2. 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)

    Time frame: From start of LC-QSPECT imaging through 12 hours following LC-QSPECT imaging

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

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

    Feasibility is defined as at least 80% of scans able to be processed.

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

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

    Spearman correlation coefficient measures the strength and direction of the linear correlation (dependence) between 2 variables after converting the raw data to ranks, giving a value between +1 and -1 inclusive, where 1 indicates perfect positive correlation, 0 indicates no correlation, and -1 indicates perfect negative correlation.

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

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

    Spearman correlation coefficient measures the strength and direction of the linear correlation (dependence) between 2 variables after converting the raw data to ranks, giving a value between +1 and -1 inclusive, where 1 indicates perfect positive correlation, 0 indicates no correlation, and -1 indicates perfect negative correlation.

  6. Correlation between the LC-QSPECT measurements and bone-turnover markers (Spearman Correlation Coefficient)

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

    Spearman correlation coefficient measures the strength and direction of the linear correlation (dependence) between 2 variables after converting the raw data to ranks, giving a value between +1 and -1 inclusive, where 1 indicates perfect positive correlation, 0 indicates no correlation, and -1 indicates perfect negative correlation.

  7. Correlation between the LC-QSPECT measurements and Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire (Spearman Correlation Coefficient)

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

    • Spearman correlation coefficient measures the strength and direction of the linear correlation (dependence) between 2 variables after converting the raw data to ranks, giving a value between +1 and -1 inclusive, where 1 indicates perfect positive correlation, 0 indicates no correlation, and -1 indicates perfect negative correlation.
    • The FACT-P scale is a tool used for assessing the health-related quality of life (QoL) in men with prostate cancer. It consists of 27 core items which assess patient function in four domains (Physical, Social/Family, Emotional, and Functional well-being), and it is further supplemented by 12 site specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert type scale, and then combined to produce a global QoL score, with a range of scores of 0 to 156. Higher scores represent better QoL.

  8. Correlation between the LC-QSPECT measurements and EuroQol-5 (EQ-5D-5L) questionnaire (Spearman Correlation Coefficient)

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

    • Spearman correlation coefficient measures the strength and direction of the linear correlation (dependence) between 2 variables after converting the raw data to ranks, giving a value between +1 and -1 inclusive, where 1 indicates perfect positive correlation, 0 indicates no correlation, and -1 indicates perfect negative correlation.
    • EQ-5D-5L is a descriptive system for health-related quality of life states in adults, consisting of five dimensions (Mobility, Self-care, Usual activities, Pain & discomfort, Anxiety & depression), each of which has five severity levels that are described by statements appropriate to that dimension. Scale Minimum: 0. Scale Maximum: 100. Higher score indicates better outcome.

  9. Correlation between the LC-QSPECT measurements and Brief Pain Inventory (BPI) questionnaire (Spearman Correlation Coefficient)

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

    • Spearman correlation coefficient measures the strength and direction of the linear correlation (dependence) between 2 variables after converting the raw data to ranks, giving a value between +1 and -1 inclusive, where 1 indicates perfect positive correlation, 0 indicates no correlation, and -1 indicates perfect negative correlation.
    • BPI score ranges from 0 to 10 with a higher score denoting a higher pain severity.

  10. Correlation between the LC-QSPECT measurements and bone turnover (Spearman Correlation Coefficient)

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

    Spearman correlation coefficient measures the strength and direction of the linear correlation (dependence) between 2 variables after converting the raw data to ranks, giving a value between +1 and -1 inclusive, where 1 indicates perfect positive correlation, 0 indicates no correlation, and -1 indicates perfect negative correlation.

  11. Percentage of times that the use of the LC-QSPECT procedure resulted in any changes in treatment plans of the patients

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

  12. Performance of the LC-QSPECT procedure using a no-gold-standard evaluation technique.

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

    • The investigators will use the no-gold-standard technique to assess whether the LC-QSPECT technique yields precise performance on the task of isotope uptake quantification, where slope and noise will be estimated and the noise-to-slope ratio (NSR) will be calculated.
    • The no-gold-standard technique can be found here: Jha AK, Caffo B, Frey EC. A no-gold-standard technique for objective assessment of quantitative nuclear-medicine imaging methods. Phys Med Biol. 2016 Apr 7;61(7):2780-800. doi: 10.1088/0031-9155/61/7/2780. Epub 2016 Mar 16. PMID: 26982626; PMCID: PMC4921224 and here: Yan Liu, Ziping Liu, Zekun Li, Daniel Thorek, Barry Siegel, Abhinav Jha, "No-gold-standard evaluation of quantitative SPECT methods for alpha-particle radiopharmaceutical therapy", Journal of Nuclear Medicine Jun 2023, 64 (supplement 1) P1331

Study contacts

Contact information is provided by the study sponsor or research team.

Abhinav K Jha, Ph.D.

CONTACT

[email protected]

314-273-2655

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Oct 28, 2025
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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