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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

Primary Purpose

Bone Metastases, Recurrent Prostate Cancer, Stage I Prostate Cancer

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
magnetic resonance imaging
fluorine F 18 sodium fluoride
positron emission tomography
computed tomography
technetium Tc 99m methylene diphosphonate
laboratory biomarker analysis
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Bone Metastases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (fluorine F 18 sodium fluoride PET)

Arm Description

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.

Outcomes

Primary Outcome Measures

Uptake of fluorine F 18 sodium fluoride on PET/CT scan
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
Determine if focal MRI abnormality is directly correlated to the metastatic tumor burden within the bones using bone scan as the reference standard.

Secondary Outcome Measures

Full Information

First Posted
August 7, 2009
Last Updated
July 1, 2014
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00956163
Brief Title
Whole Body Fluorine F 18 Sodium Fluoride PET/CT Scan and Whole Body MRI in Finding Bone Metastases in Patients With Prostate Cancer
Official Title
F-18 NaF PET for Detection of Bone Metastases in Men With Prostate Cancer: Exploratory Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic (fluorine F 18 sodium fluoride PET)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
magnetic resonance imaging
Other Intervention Name(s)
MRI, NMR imaging, NMRI, nuclear magnetic resonance imaging
Intervention Description
Undergo whole-body MRI
Intervention Type
Radiation
Intervention Name(s)
fluorine F 18 sodium fluoride
Other Intervention Name(s)
18 F-NaF, F-18 NaF
Intervention Description
Undergo fluorine F 18 sodium fluoride PET/CT scan
Intervention Type
Procedure
Intervention Name(s)
positron emission tomography
Other Intervention Name(s)
FDG-PET, PET, PET scan, tomography, emission computed
Intervention Description
Undergo fluorine F 18 sodium fluoride PET/CT scan
Intervention Type
Procedure
Intervention Name(s)
computed tomography
Other Intervention Name(s)
tomography, computed
Intervention Description
Undergo fluorine F 18 sodium fluoride PET/CT scan
Intervention Type
Radiation
Intervention Name(s)
technetium Tc 99m methylene diphosphonate
Other Intervention Name(s)
99mTc-MDP, TechneScan MDP, technetium Tc 99m medronate
Intervention Description
Undergo technetium Tc 99m methylene diphosphonate bone scan
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Uptake of fluorine F 18 sodium fluoride on PET/CT scan
Description
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.
Time Frame
Up to 24 months
Title
Incidence of focal MRI abnormality
Description
Determine if focal MRI abnormality is directly correlated to the metastatic tumor burden within the bones using bone scan as the reference standard.
Time Frame
Up to 24 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mukesh Harisinghani
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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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