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

Bone Metastases Clinical Trial

Official title:

F-18 NaF PET for Detection of Bone Metastases in Men With Prostate Cancer: Exploratory Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00956163
• Other study ID #: NCI-2011-02972
• Secondary ID: NCI-2011-02972CD
• Status: Completed
• Phase: Phase 0
• First received: August 7, 2009
• Last updated: July 1, 2014
• Start date: March 2010
• Est. completion date: May 2014

Study information

• Verified date: December 2013
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2014
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Bone Marrow Diseases
• Bone Metastases
• Bone Neoplasms
• Neoplasm Metastasis
• Prostatic Neoplasms
• Recurrent Prostate Cancer
• Stage I Prostate Cancer
• Stage IIA Prostate Cancer
• Stage IIB Prostate Cancer
• Stage III Prostate Cancer
• Stage IV Prostate Cancer

Intervention

Procedure:
• magnetic resonance imaging
Undergo whole-body MRI

Radiation:
• fluorine F 18 sodium fluoride
Undergo fluorine F 18 sodium fluoride PET/CT scan

Procedure:
• positron emission tomography
Undergo fluorine F 18 sodium fluoride PET/CT scan
• computed tomography
Undergo fluorine F 18 sodium fluoride PET/CT scan

Radiation:
• technetium Tc 99m methylene diphosphonate
Undergo technetium Tc 99m methylene diphosphonate bone scan

Other:
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 24 months	No
Primary	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.	Up to 24 months	No