Combined 18F NaF/18F FDG PET/MRI for Detection of Skeletal Metastases

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT00375830
First received: September 11, 2006
Last updated: July 7, 2016
Last verified: July 2016
  Purpose
This clinical trial studies sodium fluorine-18 (18F NaF)/fluorine-18 (18F) fluorodeoxyglucose (FDG) positron emission tomography (PET)/magnetic resonance imaging (MRI) in detecting skeletal metastases in patients with stage III-IV breast cancer or stage II-IV prostate cancer. 18F NaF and 18F FDG are radioactive substances that are absorbed by cancerous cells and allow for the cancer to be found using diagnostic procedures such as PET/MRI. PET/MRI is a procedure that combines detailed pictures of areas inside the body from PET and MRI scans and may help find and diagnose skeletal metastases in patients with breast or prostate cancer. It is not yet known whether 18F NaF/18F FDG PET/MRI is better than standard imaging methods in detecting skeletal metastases.

Condition Intervention
Cancer
Procedure: Positron Emission Tomography
Procedure: Magnetic Resonance Imaging
Radiation: Fludeoxyglucose F-18
Radiation: Fluorine F 18 Sodium Fluoride

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Combined 18F NaF/18F FDG PET/MRI for Detection of Skeletal Metastases

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Concordance between 99mTc MDP bone scan and 18F NaF/18F FDG PET/MRI as the proportion of patients where the modalities agree [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Calculate the concordance between the modalities across outcomes (combining cases and controls) and evaluate the results by calculating the kappa coefficient.


Secondary Outcome Measures:
  • Concordance in cases and controls, sensitivity, specificity, positive predicted value, and negative predictive value (per patient) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Calculated both as aggregates of the three diseases and separately by disease. Sensitivities and other summaries will only be calculated if they involve a denominator of at least 10.

  • Distribution of lesions seen on each modality (per lesion) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Calculated both as aggregates of the three diseases and separately by disease. Sensitivities and other summaries will only be calculated if they involve a denominator of at least 10.


Estimated Enrollment: 120
Study Start Date: January 2006
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diagnostic (18F NaF/18F FDG PET/MRI)
Patients undergo a combined 18F NaF and 18F FDG PET/MRI scan over 45 minutes.
Procedure: Positron Emission Tomography
Undergo 18F NaF PET/MRI
Procedure: Magnetic Resonance Imaging
Undergo 18F NaF PET/MRI
Radiation: Fludeoxyglucose F-18
105851-17-0, 18FDG, 2-Deoxy-2-(18F)Fluoro-D-Glucose, 2-F18-Fluoro-2-deoxy-D-glucose, 2-F18-Fluoro-2-deoxyglucose, 723398, FDG, fludeoxyglucose F 18, FLUDEOXYGLUCOSE F-18, Fludeoxyglucose F-18, Fludeoxyglucose F-18, Fludeoxyglucose F18, Fluorine-18 2-Fluoro-2-deoxy-D-Glucose, Fluorodeoxyglucose F18
Radiation: Fluorine F 18 Sodium Fluoride
Undergo 18F NaF PET/MRI

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patient provides written informed consent Patient is diagnosed with >= stage 3 breast cancer or >= stage 2 prostate cancer (and/or prostate-specific antigen [PSA] > 10 micrograms/L), including patient with recurrent breast or prostate cancer Patient is capable of complying with study procedures Patient is able to remain still for duration of imaging procedure (about one hour)

  • Patient is ≥ 18 years old at the time of the drug administration
  • Patient provides written informed consent
  • Patient is diagnosed with ≥ stage 3 breast cancer or ≥ stage 2 prostate cancer (and/or PSA >10 micrograms/L), including patient with recurrent breast or prostate cancer
  • Patient is capable of complying with study procedures
  • Patient is able to remain still for duration of imaging procedure (about one hour)

Exclusion Criteria:

  • Patient is < 18 years old at the time of the drug administration
  • Patient is pregnant or nursing
  • Metallic implants (contraindicated for MRI)
  • Renal function impairment preventing administration of MRI contrast
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00375830

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Risa Jiron    650-736-1598    rjiron@stanford.edu   
Principal Investigator: Andrei Iagaru         
Sub-Investigator: Eric Mittra         
Sub-Investigator: Shreyas Vasanawala         
Sub-Investigator: Robert Herfkens         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Andrei Iagaru, MD Stanford University
  More Information

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT00375830     History of Changes
Other Study ID Numbers: BONE0001  96754 
Study First Received: September 11, 2006
Last Updated: July 7, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Fluorides
Sodium Fluoride
Fluorodeoxyglucose F18
Listerine
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Local
Anti-Infective Agents

ClinicalTrials.gov processed this record on July 24, 2016