ClinicalTrials.gov
ClinicalTrials.gov Menu

NaF/FDG PET/MRI in Measuring Response to Radium Ra 223 Dichloride in Patients With Metastatic Hormone-Resistant Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02429804
Recruitment Status : Terminated (Accrual factor)
First Posted : April 29, 2015
Last Update Posted : May 30, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Andrei Iagaru, Stanford University

Brief Summary:
This pilot clinical trial studies combined fluorine F 18 sodium fluoride (NaF)/ fludeoxyglucose F 18 (FDG) positron emission tomography (PET) and magnetic resonance imaging (MRI) in measuring response to a drug, radium Ra 223 dichloride (Ra-223), in treating patients with prostate cancer that has not responded to hormone therapy and has spread to other parts of the body. Combining NaF/FDG in a simultaneous PET/MRI scan may help doctors accurately measure how well patients respond to treatment with radium Ra 223 dichloride.

Condition or disease Intervention/treatment Phase
Hormone-Resistant Prostate Cancer Metastatic Malignant Neoplasm in the Bone Metastatic Prostate Carcinoma Procedure: Contrast-enhanced Magnetic Resonance Imaging Drug: Fludeoxyglucose F-18 Drug: Fluorine F 18 Sodium Fluoride Procedure: Magnetic Resonance Imaging Procedure: Positron Emission Tomography Phase 1

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 : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Combined "One Stop Shop" NaF/FDG PET/MRI Evaluation of Response to Xofigo® in mCRPC Patients: A Pilot Study
Study Start Date : April 2015
Actual Primary Completion Date : May 15, 2017
Actual Study Completion Date : May 15, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

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.
Procedure: Contrast-enhanced Magnetic Resonance Imaging
Undergo contrast-enhanced MRI
Other Names:
  • CONTRAST ENHANCED MRI
  • Contrast-enhanced MRI

Drug: Fludeoxyglucose F-18
Given IV
Other Names:
  • 18FDG
  • FDG
  • fludeoxyglucose F 18
  • Fludeoxyglucose F18
  • Fluorine-18 2-Fluoro-2-deoxy-D-Glucose
  • Fluorodeoxyglucose F18

Drug: Fluorine F 18 Sodium Fluoride
Given IV
Other Names:
  • 18 F-NaF
  • F-18 NaF

Procedure: Magnetic Resonance Imaging
Undergo PET/MRI
Other Names:
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MRI
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging

Procedure: Positron Emission Tomography
Undergo PET/MRI
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET SCAN
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging




Primary Outcome Measures :
  1. Dichotomized treatment response at 24 weeks, based on technetium Tc-99m medronate (99mTc-MDP) bone scintigraphy intensity [ 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.

  2. 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.

  3. 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.

  4. Percent reduction at 12 weeks in NaF/FDG PET standardized uptake value [ Time Frame: 12 weeks ]
  5. Percent reduction at 12 weeks in MRI lesion size (per lesion analysis) [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
    The true positive fraction of progressions detected only with NaF/FDG PET/MRI will be estimated with 95% confidence intervals.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02429804


Locations
United States, California
Stanford University, School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
National Cancer Institute (NCI)
Investigators
Principal Investigator: Andrei Iagaru Stanford University

Responsible Party: Andrei Iagaru, Associate Professor of Radiology, Stanford University
ClinicalTrials.gov Identifier: NCT02429804     History of Changes
Other Study ID Numbers: PROS0063
NCI-2015-00553 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
ep 32653
96754
PROS0063 ( Other Identifier: Stanford University Hospitals and Clinics )
P30CA124435 ( U.S. NIH Grant/Contract )
First Posted: April 29, 2015    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Prostatic Neoplasms
Neoplasms
Neoplasms, Second Primary
Bone Neoplasms
Bone Marrow Diseases
Neoplasm Metastasis
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases
Neoplastic Processes
Pathologic Processes
Fluorides
Sodium Fluoride
Listerine
Fluorodeoxyglucose F18
Radium Ra 223 dichloride
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents