NaF PET/MRI Evaluation for Bone Metastases in Breast Cancer
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/6/2019 |
| Start Date: | March 1, 2014 |
| End Date: | December 21, 2018 |
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.
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.
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.
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
We found this trial at
1
site
Cleveland, Ohio 44106
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