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| ID | Type | Description | Link |
|---|---|---|---|
| R01EB031962 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute for Biomedical Imaging and Bioengineering (NIBIB) | NIH |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria - Patients:
Exclusion Criteria - Patients:
Eligibility Criteria - Physicians:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Abhinav K Jha, Ph.D. | Contact | 314-273-2655 | a.jha@wustl.edu |
| Name | Affiliation | Role |
|---|---|---|
| Abhinav K Jha, Ph.D. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
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| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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Deidentified SPECT imaging data, quantitative imaging metrics, and limited clinical variables (e.g., demographics, treatment cycle, administered activity, relevant lab values, clinical outcome measures) may be shared with qualified researchers at academic, nonprofit, or industry institutions for secondary analyses of image data, dosimetry, quantitative modeling, or clinical outcomes related to Radium-223 therapy.
Beginning 12 months after publication of primary results; available for at least 5 years.
Data will be shared through a controlled-access repository. Access will require a brief proposal and a signed data use agreement.
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 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 | Feasibility is defined as at least 80% of scans able to be processed. | Through completion of LC-QSPECT imaging (estimated to be 3 months) |
| 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. | Through completion of Xofigo treatment (estimated to be 6 months) |
| Correlation between the LC-QSPECT measurements and PSA doubling time (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. | Through completion of Xofigo treatment (estimated to be 6 months) |
| Correlation between the LC-QSPECT measurements and bone-turnover markers (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. | Through completion of Xofigo treatment (estimated to be 6 months) |
| Correlation between the LC-QSPECT measurements and Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire (Spearman Correlation Coefficient) |
| Through completion of Xofigo treatment (estimated to be 6 months) |
| Correlation between the LC-QSPECT measurements and EuroQol-5 (EQ-5D-5L) questionnaire (Spearman Correlation Coefficient) |
| Through completion of Xofigo treatment (estimated to be 6 months) |
| Correlation between the LC-QSPECT measurements and Brief Pain Inventory (BPI) questionnaire (Spearman Correlation Coefficient) |
| Through completion of Xofigo treatment (estimated to be 6 months) |
| Correlation between the LC-QSPECT measurements and bone turnover (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. | Through completion of Xofigo treatment (estimated to be 6 months) |
| Percentage of times that the use of the LC-QSPECT procedure resulted in any changes in treatment plans of the patients | Through completion of Xofigo treatment (estimated to be 6 months) |
| Performance of the LC-QSPECT procedure using a no-gold-standard evaluation technique. |
| Through completion of LC-QSPECT imaging (estimated to be 3 months) |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |