NaF PET/MRI Evaluation for Bone Metastases in Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Case Comprehensive Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT02103634
First received: April 1, 2014
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Malignant Neoplasm of Breast TNM Staging Distant Metastasis (M)
Untreated Bone Metastases
Device: NaF PET/MRI
Device: NaF PET/CT
Device: FDG PET/CT

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: NaF PET/MRI Evaluation for Bone Metastases in Breast Cancer

Resource links provided by NLM:


Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:
  • Sensitivity of NaF PET/MRI [ Time Frame: 2 years after beginning of study ] [ Designated as safety issue: No ]
    The difference in the number of lesions detected by the two imaging methods using McNamar's test


Secondary Outcome Measures:
  • Image Quality [ Time Frame: 2 years after beginning of study ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Difference in bone metastases detected by MRI attenuation correction images compared to diagnostic quality images.


Estimated Enrollment: 50
Study Start Date: March 2014
Estimated Study Completion Date: July 2025
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

Detailed Description:

The primary aim of this study is to assess NaF PET/MRI compared to FDG PET/CT, NaF PET/CT and standard of care imaging made available for assessment of bone metastases in breast cancer. 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. Researchers 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. 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 review of surveillance standard of care imaging up to 6 months after the NaF 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 FDG PET/CT study, would there have been a change in subsequent patient management.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Referred to a Nuclear Medicine department for FDG PET/CT for initial staging or restaging of breast cancers with positive standard of care imaging (or seen on FDG study) showing bone metastases that have not been treated
  • 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)
  • < 18 years of age
  • 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
  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: NCT02103634

Contacts
Contact: Robert S Jones, MD 216-844-7611 robert.jones@uhhospitals.org

Locations
United States, Ohio
University Hospitals Case Medical Center, Case Comprehensive Cancer Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Robert Jones, MD    216-844-7611    robert.jones@uhhsopitals.org   
Principal Investigator: Robert Jones, MD         
Sponsors and Collaborators
Case Comprehensive Cancer Center
  More Information

No publications provided

Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02103634     History of Changes
Other Study ID Numbers: CASE5113
Study First Received: April 1, 2014
Last Updated: July 14, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Case Comprehensive Cancer Center:
breast cancer
FDG PET/CT
MRI
NaF PET/MRI
NaF PET/CT

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Bone Neoplasms
Neoplasms by Site
Breast Diseases
Bone Marrow Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases

ClinicalTrials.gov processed this record on July 23, 2014