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NaF PET/MRI Evaluation for Bone Metastases in Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT02103634
First received: April 1, 2014
Last updated: August 4, 2017
Last verified: August 2017
April 1, 2014
August 4, 2017
March 1, 2014
February 3, 2017   (Final data collection date for primary outcome measure)
Sensitivity of NaF PET/MRI [ Time Frame: 2 years after beginning of study ]
The difference in the number of lesions detected by the two imaging methods using McNamar's test
Same as current
Complete list of historical versions of study NCT02103634 on ClinicalTrials.gov Archive Site
  • Image Quality [ Time Frame: 2 years after beginning of study ]
    Mean quality score ranging from 1-5 using different methods will be compared using paired t-tests. With a sample size of 150 lesions, a difference of 0.25 points in mean quality score can be detected with 86% power.
  • Positive predictive value of MRI sequences [ Time Frame: 2 years from beginning of study ]
    The difference in positive predictive value of bone metastases detected by MRI sequences as compared to other modalities as calculated using McNamar's test.
  • Negative predictive value of MRI sequences [ Time Frame: 2 years from beginning of study ]
    The difference in Negative predictive value of bone metastases detected by MRI sequences as compared to other modalities as calculated using McNamar's test.
  • Specificity of MRI sequences [ Time Frame: 2 years from beginning of study ]
    The difference in specificity of bone metastases detected by MRI sequences as compared to other modalities as calculated using McNamar's test.
  • attenuation correction [ Time Frame: 2 years after beginning of study ]
    Difference in attenuation correction of NaF MRI-based and NaF CT-based images as calculated using McNamar's test.
  • localization [ Time Frame: 2 years after beginning of study ]
    Difference in localization of NaF MRI-based and NaF CT-based images as calculated using McNamar's test.
  • Evaluation of Bone Metastases [ Time Frame: 2 years after beginning of study ]
    Difference in bone metastases detected by MRI attenuation correction images compared to diagnostic quality images.
Same as current
Not Provided
Not Provided
 
NaF PET/MRI Evaluation for Bone Metastases in Breast Cancer
NaF PET/MRI Evaluation for Bone Metastases in Breast Cancer

This study will look at two new technologies being developed for measuring cancer in bones. One of these technologies is a substance called Sodium Fluoride (NaF). Fluoride is a normal body substance. The amount that patients will receive has been shown to be very safe. One study of over 400 patients showed no adverse reactions after receiving the recommended dosage.

NaF (known as a radiotracer) is taken up into the bones under a normal process and researchers can measure the amount within patient's bones through an imaging system called a Positron Emission Tomography/Magnetic Resonance Imaging (PET/MRI). This system combines aspects of both a PET study as part of the regular standard of care and an MRI study. The belief is that the combination of these two studies will be better than either study alone.People who have enrolled in this study will receive their clinically requested PET/CT scan as part of their normal diagnostic care and will follow all the said recommendations for this study such as not being pregnant, having fasted overnight, etc. Subjects will return within 7 days for a 10 mCi NaF PET/MRI study. The patients' imaging time will be up to 120 minutes depending on the MRI sequences acquired. Imaging for the PET portion of the study will take approximately 20-30 minutes with the rest of the time devoted to MRI sequences.

The primary aim of this study is to assess NaF PET/MRI compared to NaF PET/CT and standard of care imaging made available for assessment of bone metastases in all cancers as well as other standard of care indications for MDP bone scintigraphy. The study will use both the currently available and approved MRI sequences for attenuation correction and localization as well as non FDA approved sequences to assess the ability of the modality to identify bone metastases.

Study Goals:

  1. Assess the sensitivity, specificity, accuracy of NaF PET/MRI vs. Naf PET/CT vs. current standard of care imaging. This will be done on a lesion by lesion basis based on a prior study looking at NaF PET/CT (14). Lesions that are positive on NaF PET/MRI but not on other imaging will be followed up on future imaging to see if they eventually become positive given that physiology changes before anatomy. Follow up will include both repeat NaF PET/CT (PET/MRI) studies (as per standard of care MDP bone scintigraphy indications) as well as review of other surveillance standard of care imaging up to 6 months after the NaF PET/CT (PET/MRI) was done.
  2. Assess various NaF MRI sequences for attenuation correction and localization both from approved and developmental sequences compared to NaF CT attenuation corrected images through software.
  3. Assess the ability of MRI sequences acquired for attenuation correction and localization to evaluate bone metastases in comparison to other modalities.
  4. Assess the image quality of various NaF MRI sequences acquired for attenuation correction and localization using both approved and developmental sequences.
  5. Ascertain, if there are lesions identified on the NaF PET/MRI study but not seen on the NaF PET/CT study (or other standard of care imaging) or vice versa.
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
  • Malignant Neoplasm of Breast TNM Staging Distant Metastasis (M)
  • Untreated Bone Metastases
  • Device: NaF PET/MRI
  • Device: NaF PET/CT
    NaF PET/CT images will be obtained through fusion software. Researchers will fuse the Non AC and AC NaF images with the low dose CT obtained in the FDG PET/CT study.
  • Device: FDG PET/CT
Experimental: Lesion Imaging
Image patients with the standard of care of a FDG PET/CT and the experimental method of the NaF PET/MRI and compare the number of images found within and between patients to determine the most effective way of looking at breast cancers metastasized to bone
Interventions:
  • Device: NaF PET/MRI
  • Device: NaF PET/CT
  • Device: FDG PET/CT
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
February 3, 2017
February 3, 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Referred to University Hospitals Cleveland Medical Center Nuclear Medicine for methylene diphosphonate (MDP) Bone Scintigraphy
  • Must understand and voluntarily sign an Informed consent form after the contents have been fully explained to them.
  • Patients must have no contra-indications to PET/CT or MRI (Patients will NOT be receiving either CT or MRI contrast and thus, those contraindications are not exclusionary).

Exclusion Criteria:

  • Patients who cannot tolerate imaging up to 120 minutes of total imaging (breaks of several minutes between imaging will be available)
  • Pregnant or breast feeding women.
  • Healthy volunteers
  • Inability to comply with instructions
  • MRI contraindications Include:

    • Patients with ferromagnetic or otherwise non-MRI compatible aneurysm clips
    • Patients with implanted pacemaker or implanted defibrillator device
    • Patients with contraindications for MRI due to embedded foreign metallic objects. Bullets, shrapnel, metalwork fragments, or other metallic material adds unnecessary risk to the patient
    • Implanted medical device not described above that is not MRI-compatible
    • Known history of claustrophobia
    • Contrast contraindications not included since patients will not be receiving MRI or CT contrast as part of this study
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02103634
CASE5113
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Not Provided
Case Comprehensive Cancer Center
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Robert S Jones, MD University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
Case Comprehensive Cancer Center
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP