Low-Count Quantitative SPECT for Men Treated With Radium-223
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorWashington University School of Medicine
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Low-count quantitative single-photon emission computed tomography imaging
DeviceLC-QSPECT scans will be performed between 6 and 36 hours after administration of Xofigo during Cycles 1 and 3.
Treatment groups
38 Participants
are divided into 2 treatment groupsGroup A: LC-QSPECTExperimental treatment 1 intervention
Group B: PhysiciansNo intervention 0 interventions
Trial outcomes
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.
Time frame
Through collection of ex vivo sample (estimated to be 3 months)Secondary outcomes
1
LC-QSPECT related adverse events
Time frame
From start of LC-QSPECT imaging through 12 hours following LC-QSPECT imaging2
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 imaging3
Feasibility of conducting LC-QSPECT will be determined by percentage of SPECT scans that can be processed using the investigators' computational method
Feasibility is defined as at least 80% of scans able to be processed.
Time frame
Through completion of LC-QSPECT imaging (estimated to be 3 months)4
Correlation between the LC-QSPECT measurements and PSA (Spearman Correlation Coefficient)
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.
Time frame
Through completion of Xofigo treatment (estimated to be 6 months)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Washington University School of Medicine
Lead sponsor
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Collaborator
Source ClinicalTrials.gov