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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00956163
First received: August 7, 2009
Last updated: July 1, 2014
Last verified: December 2013

August 7, 2009
July 1, 2014
March 2010
January 2011   (final data collection date for primary outcome measure)
  • Uptake of fluorine F 18 sodium fluoride on PET/CT scan [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Determine if focal MRI abnormality is directly correlated to the metastatic tumor burden within the bones using bone scan as the reference standard.
sensitivity for the detection of bone metastases [ Time Frame: 6 months (end of pilot study) and 2½ years (end of study) ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00956163 on ClinicalTrials.gov Archive Site
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Whole Body Fluorine F 18 Sodium Fluoride PET/CT Scan and Whole Body MRI in Finding Bone Metastases in Patients With Prostate Cancer
F-18 NaF PET for Detection of Bone Metastases in Men With Prostate Cancer: Exploratory Study

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.

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.

Interventional
Phase 0
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • 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
    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
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.
Interventions:
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
May 2014
January 2011   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00956163
NCI-2011-02972, NCI-2011-02972, CDR0000666327, MGH-09364, 09-364, 8336, P30CA006516, N01CM37120
Not Provided
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Not Provided
Principal Investigator: Mukesh Harisinghani Massachusetts General Hospital
National Cancer Institute (NCI)
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP