NaF PET/MRI Evaluation for Bone Metastases in Breast Cancer

NCT02103634 | Completed DMC FDA Device

• 1 other identifier: CASE5113
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Sensitivity of NaF PET/MRI

  The difference in the number of lesions detected by the two imaging methods using McNamar's test

  2 years after beginning of study

Secondary Outcomes (7)

• Image Quality

  2 years after beginning of study

• Positive predictive value of MRI sequences

  2 years from beginning of study

• Negative predictive value of MRI sequences

  2 years from beginning of study

• Specificity of MRI sequences

  2 years from beginning of study

• attenuation correction

  2 years after beginning of study

Study Arms (1)

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; Device: FDG PET/CT

Interventions

NaF PET/MRI DEVICE

Lesion Imaging

NaF PET/CT DEVICE

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.

Lesion Imaging

FDG PET/CT DEVICE

Lesion Imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

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.

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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Robert S Jones, MD

  University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2014
• First Posted: April 4, 2014
• Study Start: March 1, 2014
• Primary Completion: December 21, 2018
• Study Completion: December 21, 2018
• Last Updated: July 29, 2020

Record last verified: 2020-07

Locations

US (1)