Whole Body Fluorine F 18 Sodium Fluoride PET/CT Scan and Whole Body MRI in Finding Bone Metastases in Patients With Prostate Cancer
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ClinicalTrials.gov Identifier: NCT00956163 |
Recruitment Status
:
Completed
First Posted
: August 11, 2009
Last Update Posted
: July 2, 2014
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Condition or disease | Intervention/treatment | Phase |
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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 |
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 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 |

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.
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Procedure: magnetic resonance imaging
Undergo whole-body MRI
Other Names:
Radiation: fluorine F 18 sodium fluoride
Undergo fluorine F 18 sodium fluoride PET/CT scan
Other Names:
Procedure: positron emission tomography
Undergo fluorine F 18 sodium fluoride PET/CT scan
Other Names:
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:
Other: laboratory biomarker analysis
Correlative studies
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- 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.
- 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.

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

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): NCT00956163
United States, Massachusetts | |
Massachusetts General Hospital Cancer Center | |
Boston, Massachusetts, United States, 02114 |
Principal Investigator: | Mukesh Harisinghani | Massachusetts General Hospital |
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 Key Record Dates |
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 |