- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02429804
NaF/FDG PET/MRI in Measuring Response to Radium Ra 223 Dichloride in Patients With Metastatic Hormone-Resistant Prostate Cancer
Combined "One Stop Shop" NaF/FDG PET/MRI Evaluation of Response to Xofigo® in mCRPC Patients: A Pilot Study
Study Overview
Status
Conditions
Detailed Description
PRIMARY OBJECTIVES:
I. Estimate the performance of simultaneous NaF/FDG PET/MRI for the prediction of treatment response in patients with metastatic castrate resistant prostate cancer (mCRPC).
II. Estimate the performance of simultaneous NaF/FDG PET/MRI for detection of extra-skeletal disease progression during treatment in mCRPC patients.
OUTLINE:
Patients receive 18F NaF and 18F FDG intravenously (IV) over 30 seconds-1 minute and then undergo PET/MRI and contrast-enhanced MRI after 45-60 minutes. Patients undergo imaging at baseline, after course 3 (12 weeks), and after course 6 (24 weeks) of treatment with Ra-223.
After completion of study, patients are followed up for up to 12 months.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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California
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Stanford, California, United States, 94305
- Stanford University, School of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Provides written informed consent
- Diagnosed with mCRPC and painful bone metastases, referred for Xofigo (radium Ra 223 dichloride)
- Able to remain still for duration of the imaging procedure (about one hour)
Exclusion Criteria:
- Metallic implants
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Diagnostic (18F NaF/18F FDG PET/MRI, contrast-enhanced MRI)
Patients receive 18F NaF and 18F FDG IV over 30 seconds-1 minute and then undergo PET/MRI and contrast-enhanced MRI after 45-60 minutes.
Patients undergo imaging at baseline, after course 3 (12 weeks), and after course 6 (24 weeks) of treatment with Ra-223.
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Undergo contrast-enhanced MRI
Other Names:
Undergo PET/MRI
Other Names:
Undergo PET/MRI
Other Names:
Given IV
Other Names:
Given IV
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dichotomized treatment response at 24 weeks, based on technetium Tc-99m medronate (99mTc-MDP) bone scintigraphy intensity
Time Frame: 24 weeks
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Logistic regression of per-lesion 24-week response will be performed on percent reduction in lesion maximum standardized uptake value and percent reduction in lesion MR size.
The logistic regression will include an adjustment for clustering.
The receiver operating characteristic curve from the logistic regression will be graphed to give some idea of the relative sensitivity and specificity of the model.
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24 weeks
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Dichotomized treatment response at 24 weeks, based on computed tomography (CT) lesion size
Time Frame: 24 weeks
|
Logistic regression of per-lesion 24-week response will be performed on percent reduction in lesion maximum standardized uptake value and percent reduction in lesion MR size.
The logistic regression will include an adjustment for clustering.
The receiver operating characteristic curve from the logistic regression will be graphed to give some idea of the relative sensitivity and specificity of the model.
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24 weeks
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Dichotomized treatment response at 24 weeks, based on alkaline phosphatase (ALP) measurements (per lesion analysis)
Time Frame: 24 weeks
|
Logistic regression of per-lesion 24-week response will be performed on percent reduction in lesion maximum standardized uptake value and percent reduction in lesion MR size.
The logistic regression will include an adjustment for clustering.
The receiver operating characteristic curve from the logistic regression will be graphed to give some idea of the relative sensitivity and specificity of the model.
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24 weeks
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Percent reduction at 12 weeks in NaF/FDG PET standardized uptake value
Time Frame: 12 weeks
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12 weeks
|
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Percent reduction at 12 weeks in MRI lesion size (per lesion analysis)
Time Frame: 12 weeks
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12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Presence of new or regrowing extra-skeletal disease at 12 and/or 24 weeks on NaF/FDG PET/MRI that is not present on corresponding standard-of-care 99mTc-MDP bone scintigraphy and CT (per lesion analysis)
Time Frame: Up to 24 weeks
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Up to 24 weeks
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True status (true positive or false positive) of such lesions after 12 months of follow-up, based on all information except NaF/FDG PET/MRI (per lesion analysis)
Time Frame: 12 months
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The true positive fraction of progressions detected only with NaF/FDG PET/MRI will be estimated with 95% confidence intervals.
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12 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Andrei Iagaru, Stanford University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Male
- Prostatic Diseases
- Neoplasms
- Prostatic Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents, Local
- Anti-Infective Agents
- Antiviral Agents
- Antimetabolites
- Protective Agents
- Radiopharmaceuticals
- Cariostatic Agents
- Fluorodeoxyglucose F18
- Listerine
- Fluorides
- Sodium Fluoride
- Deoxyglucose
Other Study ID Numbers
- PROS0063 (Other Identifier: Stanford University Hospitals and Clinics)
- P30CA124435 (U.S. NIH Grant/Contract)
- NCI-2015-00553 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- ep 32653
- 96754 (Other Identifier: Stanford University Alternate IRB Approval Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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