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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 is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00956163
First received: August 7, 2009
Last updated: May 1, 2013
Last verified: May 2013
History of Changes
  Purpose

This clinical trial is studying whole body fluorine F 18 sodium fluoride PET/CT scan and whole body 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 Intervention
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
Radiation: technetium Tc 99m methylene diphosphonate

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: F-18 NaF PET for Detection of Bone Metastases in Men With Prostate Cancer: Exploratory Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 50
Study Start Date: March 2010
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
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
Radiation: technetium Tc 99m methylene diphosphonate
Undergo technetium Tc 99m methylene diphosphonate bone scan
Other Names:
  • 99mTc-MDP
  • TechneScan MDP
  • technetium Tc 99m medronate

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed primary prostate cancer
  • At high risk for bone metastases based on rising PSA levels despite androgen-deprivation therapy, PSA > 10 ng/mL, and/or PSA doubling time of ≤ 10 months
  • ECOG performance status 0-1

  • No uncontrolled concurrent illness including, but not limited to, any of the following:

    • Ongoing or active infection
    • Symptomatic congestive heart failure
    • Unstable angina pectoris
    • Cardiac arrhythmia
    • Psychiatric illness or social situations that would limit compliance with study requirements
  • No known contraindications to MRI such as presence of MRI-incompatible devices (e.g., pacemakers and certain aneurysm clips), severe claustrophobia, or any other condition that would preclude proximity to a strong magnetic field
  • No patients who are unable to tolerate or who have a life-threatening allergy to technetium Tc 99m methylene diphosphonate or fluorine F 18 sodium fluoride

  • At least 7 days since prior and no concurrent other investigational therapeutic agents

    • No other investigational agents for > 7 days after completion of study treatment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00956163

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

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00956163     History of Changes
Other Study ID Numbers: NCI-2011-02972, 09-364, CDR0000666327, MGH-09364
Study First Received: August 7, 2009
Last Updated: May 1, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms, Second Primary
Prostatic Neoplasms
Bone Neoplasms
Bone Marrow Diseases
Neoplastic Processes
Neoplasms
Pathologic Processes
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
 Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases
Methylene diphosphonate
Diphosphonates
Fluorides
Sodium Fluoride
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Cariostatic Agents
Protective Agents

ClinicalTrials.gov processed this record on May 21, 2013