Whole Body Fluorine F 18 Sodium Fluoride PET/CT Scan and Whole Body MRI in Finding Bone Metastases in Patients With Prostate Cancer

Study Description

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Brief Summary:

This phase 0 trial studies whole body fluorine F 18 sodium fluoride positron emission tomography (PET)/computed tomography (CT) scan and whole body magnetic resonance imaging (MRI) in finding bone metastases in patients with prostate cancer. Diagnostic procedures, such as whole body fluorine F 18 sodium fluoride PET/CT scan and whole body MRI, may help find and diagnose bone metastases.

Condition or disease	Intervention/treatment	Phase
Bone Metastases; Recurrent Prostate Cancer; Stage I Prostate Cancer; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer; Stage III Prostate Cancer; Stage IV Prostate Cancer	Procedure: magnetic resonance imaging; Radiation: fluorine F 18 sodium fluoride; Procedure: positron emission tomography; Procedure: computed tomography; Radiation: technetium Tc 99m methylene diphosphonate; Other: laboratory biomarker analysis	Early Phase 1

Detailed Description:

PRIMARY OBJECTIVES:

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	50 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Diagnostic
Official Title:	F-18 NaF PET for Detection of Bone Metastases in Men With Prostate Cancer: Exploratory Study
Study Start Date :	March 2010
Actual Primary Completion Date :	January 2011
Actual Study Completion Date :	May 2014

Arms and Interventions

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Arm

Intervention/treatment

Experimental: 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.

Procedure: magnetic resonance imaging; Undergo whole-body MRI; Other Names: MRI; NMR imaging; NMRI; nuclear magnetic resonance imaging Radiation: fluorine F 18 sodium fluoride; Undergo fluorine F 18 sodium fluoride PET/CT scan; Other Names: 18 F-NaF; F-18 NaF Procedure: positron emission tomography; Undergo fluorine F 18 sodium fluoride PET/CT scan; Other Names: FDG-PET; PET; PET scan; tomography, emission computed Procedure: computed tomography; Undergo fluorine F 18 sodium fluoride PET/CT scan; Other Name: tomography, computed Radiation: technetium Tc 99m methylene diphosphonate; Undergo technetium Tc 99m methylene diphosphonate bone scan; Other Names: 99mTc-MDP; TechneScan MDP; technetium Tc 99m medronate Other: laboratory biomarker analysis; Correlative studies

Outcome Measures

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Primary Outcome Measures :

1. Uptake of fluorine F 18 sodium fluoride on PET/CT scan [ Time Frame: Up to 24 months ]
   Determine if increased uptake of 18F-fluoride on PET/CT scan is directly correlated to the metastatic tumor burden within the bones using bone scan as the reference standard.
2. Incidence of focal MRI abnormality [ Time Frame: Up to 24 months ]
   Determine if focal MRI abnormality is directly correlated to the metastatic tumor burden within the bones using bone scan as the reference standard.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Any ethnic group
• 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 may not receive any other investigational therapeutic agents from within 7 days prior to study drug administration through 7 days following study drug administration
• 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

Contacts and Locations

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Locations

United States, Massachusetts
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

Principal Investigator:	Mukesh Harisinghani	Massachusetts General Hospital

More Information

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Responsible Party:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00956163 History of Changes
Other Study ID Numbers:	NCI-2011-02972; NCI-2011-02972 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ); CDR0000666327; MGH-09364; 09-364 ( Other Identifier: Massachusetts General Hospital Cancer Center ); 8336 ( Other Identifier: CTEP ); P30CA006516 ( U.S. NIH Grant/Contract ); N01CM37120 ( U.S. NIH Grant/Contract )
First Posted:	August 11, 2009
Last Update Posted:	July 2, 2014
Last Verified:	December 2013

Additional relevant MeSH terms:

Prostatic Neoplasms; Neoplasm Metastasis; Bone Neoplasms; Bone Marrow Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Neoplastic Processes; Pathologic Processes; Bone Diseases; Musculoskeletal Diseases; Hematologic Diseases	Fluorides; Sodium Fluoride; Listerine; Methylene diphosphonate; Diphosphonates; Technetium Tc 99m Medronate; Cariostatic Agents; Protective Agents; Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Bone Density Conservation Agents; Radiopharmaceuticals; Molecular Mechanisms of Pharmacological Action