Whole Body Fluorine F 18 Sodium Fluoride PET/CT Scan and Whole Body MRI in Finding Bone Metastases in Patients With Prostate Cancer
NCT ID: NCT00956163
Last Updated: 2014-07-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
50 participants
INTERVENTIONAL
2010-03-31
2014-05-31
Brief Summary
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Detailed Description
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I. To evaluate the sensitivity and specificity of whole-body fluorine F 18 sodium fluoride PET/CT scan in detecting bone metastases in patients with high-risk prostate cancer using bone scan as the reference standard.
II. To evaluate the sensitivity and specificity of whole-body MRI in detecting bone metastases in patients with high-risk prostate cancer using bone scan as the reference standard.
OUTLINE:
Patients undergo technetium Tc 99m methylene diphosphonate bone scan, fluorine F 18 sodium fluoride PET/CT scan, and whole-body MRI for the detection of bone metastases. Patients with discordant imaging results (negative bone scan and positive PET/CT scan and/or MRI) undergo additional imaging at 6, 12, 18, and 24 months.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Diagnostic (fluorine F 18 sodium fluoride PET)
Patients undergo technetium Tc 99m methylene diphosphonate bone scan, fluorine F 18 sodium fluoride PET/CT scan, and whole-body MRI for the detection of bone metastases. Patients with discordant imaging results (negative bone scan and positive PET/CT scan and/or MRI) undergo additional imaging at 6, 12, 18, and 24 months.
magnetic resonance imaging
Undergo whole-body MRI
fluorine F 18 sodium fluoride
Undergo fluorine F 18 sodium fluoride PET/CT scan
positron emission tomography
Undergo fluorine F 18 sodium fluoride PET/CT scan
computed tomography
Undergo fluorine F 18 sodium fluoride PET/CT scan
technetium Tc 99m methylene diphosphonate
Undergo technetium Tc 99m methylene diphosphonate bone scan
laboratory biomarker analysis
Correlative studies
Interventions
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magnetic resonance imaging
Undergo whole-body MRI
fluorine F 18 sodium fluoride
Undergo fluorine F 18 sodium fluoride PET/CT scan
positron emission tomography
Undergo fluorine F 18 sodium fluoride PET/CT scan
computed tomography
Undergo fluorine F 18 sodium fluoride PET/CT scan
technetium Tc 99m methylene diphosphonate
Undergo technetium Tc 99m methylene diphosphonate bone scan
laboratory biomarker analysis
Correlative studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Pathologically proven prostate cancer with high risk for bone metastases
* Rising prostate-specific antigen (PSA) despite androgen deprivation therapy (ADT), PSA \> 10 ng/mL
* Ability to understand and the willingness to sign a written combined Health Insurance Portability and Accountability Act (HIPAA) and informed consent document
* Patients Eastern Cooperative Oncology Group (ECOG) performance is =\< 1
Exclusion Criteria
* Patients with known contraindications to MR imaging such as presence of MRI incompatible devices such as pacemakers and certain aneurysm clips, severe claustrophobia, or any other condition which would preclude proximity to a strong magnetic field; this exclusion is a standard of practice
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements; patients in this category are excluded to reduce medical risk to their safety and to avoid confounding variables in regard to the possibility of adverse events
* Patient is unable to tolerate or has a lifer threatening allergy to the radiopharmaceutical used for bone scan or 18F-fluoride PET
18 Years
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Mukesh Harisinghani
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Countries
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Other Identifiers
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NCI-2011-02972
Identifier Type: REGISTRY
Identifier Source: secondary_id
CDR0000666327
Identifier Type: -
Identifier Source: secondary_id
MGH-09364
Identifier Type: -
Identifier Source: secondary_id
09-364
Identifier Type: OTHER
Identifier Source: secondary_id
8336
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2011-02972
Identifier Type: -
Identifier Source: org_study_id
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