NaF PET/MRI Evaluation for Bone Metastases in Breast Cancer

Completed

Conditions studied: Malignant Neoplasm of Breast TNM Staging Distant Metastasis (M), Untreated Bone Metastases

In brief

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.

Key facts

Study ID

NCT02103634

Run by

Case Comprehensive Cancer Center

People needed

29

Starts

2014-03-01

Expected to finish

2018-12-21

Last updated by the study team

2020-07-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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

Where it is running

• University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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