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

July 1, 2014 updated by: National Cancer Institute (NCI)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.
Other: laboratory biomarker analysis
Correlative studies
Procedure: magnetic resonance imaging
Undergo whole-body MRI
Other Names:
  • MRI
  • NMRI
  • nuclear magnetic resonance imaging
  • NMR 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:
  • PET
  • FDG-PET
  • PET scan
  • tomography, emission computed
Procedure: computed tomography
Undergo fluorine F 18 sodium fluoride PET/CT scan
Other Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 24 months
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.
Up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Mukesh Harisinghani, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

August 7, 2009

First Submitted That Met QC Criteria

August 10, 2009

First Posted (Estimate)

August 11, 2009

Study Record Updates

Last Update Posted (Estimate)

July 2, 2014

Last Update Submitted That Met QC Criteria

July 1, 2014

Last Verified

December 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI-2011-02972 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • P30CA006516 (U.S. NIH Grant/Contract)
  • CDR0000666327
  • MGH-09364
  • 09-364 (Other Identifier: Massachusetts General Hospital Cancer Center)
  • 8336 (CTEP)
  • N01CM37120 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Recurrent Prostate Cancer

Clinical Trials on laboratory biomarker analysis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe