Clinical trial NCT02103634: NaF PET/MRI Evaluation for Bone Metastases in Breast Cancer
Official title: NaF PET/MRI Evaluation for Bone Metastases in Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malignant Neoplasm of Breast TNM Staging Distant Metastasis (M)
Untreated Bone Metastases
Keywords: breast cancer
FDG PET/CT
MRI
NaF PET/MRI
NaF PET/CT
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-04-04
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Breast cancer patients who present for bone imaging as per Tc-methylene diphosphonate (MDP) bone scan standard of care indications

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity of NaF PET/MRI
timeFrame: 2 years after beginning of study
Secondary outcomes:
measure: Image Quality
timeFrame: 2 years after beginning of study
measure: Positive predictive value of MRI sequences
timeFrame: 2 years from beginning of study
measure: Negative predictive value of MRI sequences
timeFrame: 2 years from beginning of study
measure: Specificity of MRI sequences
timeFrame: 2 years from beginning of study
measure: attenuation correction
timeFrame: 2 years after beginning of study
measure: localization
timeFrame: 2 years after beginning of study
measure: Evaluation of Bone Metastases
timeFrame: 2 years after beginning of study
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
name: Robert S Jones, MD
role: PRINCIPAL_INVESTIGATOR
References: