Bridging Study of C11 PiB and F18 Flutemetamol Brain PET
| Status: | Completed |
|---|---|
| Conditions: | Alzheimer Disease |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 30 - Any |
| Updated: | 4/21/2016 |
| Start Date: | July 2012 |
| End Date: | March 2016 |
The intent of this research protocol is to test the equivalency of two amyloid imaging drugs
(C11 Pittsburgh Compound B and F18 Flutemetamol). The investigators hypothesize that there
will be no significant difference in the distribution of the agents to areas of amyloid
deposition in the brain or to other normal brain structures. Recent data have shown
similarity in the distribution of the drugs in subjects with AD or mild cognitive impairment
(MCI). No comparison data of the two PET drugs in normal subjects has been published. It is
important to understand differences in the images and biodistribution from the two drugs in
normal subjects as nonspecific accumulation of the drugs in brain structures such as white
matter appear to differ slightly and could affect image performance.
The current clinical functional imaging standard for patients with indeterminate cognitive
impairment is FDG PET. To allow a comparison of the PET amyloid imaging compounds with FDG
PET, FDG PET scans will also be important to acquire in the subjects for comparison.
(C11 Pittsburgh Compound B and F18 Flutemetamol). The investigators hypothesize that there
will be no significant difference in the distribution of the agents to areas of amyloid
deposition in the brain or to other normal brain structures. Recent data have shown
similarity in the distribution of the drugs in subjects with AD or mild cognitive impairment
(MCI). No comparison data of the two PET drugs in normal subjects has been published. It is
important to understand differences in the images and biodistribution from the two drugs in
normal subjects as nonspecific accumulation of the drugs in brain structures such as white
matter appear to differ slightly and could affect image performance.
The current clinical functional imaging standard for patients with indeterminate cognitive
impairment is FDG PET. To allow a comparison of the PET amyloid imaging compounds with FDG
PET, FDG PET scans will also be important to acquire in the subjects for comparison.
The specific aims of this research proposal are outlined below.
1. Compare C11 PiB and F18 Flutemetamol in the same subjects to determine their diagnostic
accuracy in AD and normal subjects.
We have conduced 800 C11 PiB PET scans in subjects at Mayo. Only one of these subjects
was imaged with both C11 PiB and an F18 amyloid imaging agent (AV-138). Subtle
differences are noted in the intensity of accumulation possibly due to the isotope
differences as can be seen in the figure below (Figure 1). These data are not
sufficient to understand the different characteristics or determine equivalent accuracy
of the C11 and F18 drugs. We therefore propose acquiring sufficient data to help
characterize the two drugs. We will scan both AD and normal subjects to allow us to
understand the diagnostic accuracy of the two drugs.
2. Determine the relative differences in biodistribution of the PET agents and what
corrections could be made to allow for adjustments of the data obtained using C11 PiB
that will allow accurate comparisons with F18 Flutemetamol data in the same subjects.
If biodistribution differences in the two drugs are found, we will attempt to estimate
quantitative correction factors in the C11 images to help to data obtained from the
scans be comparable to future serial F18 Flutemetamol data.
3. Acquire FDG PET in the subjects to compare FDG PET imaging to PiB imaging.
1. Compare C11 PiB and F18 Flutemetamol in the same subjects to determine their diagnostic
accuracy in AD and normal subjects.
We have conduced 800 C11 PiB PET scans in subjects at Mayo. Only one of these subjects
was imaged with both C11 PiB and an F18 amyloid imaging agent (AV-138). Subtle
differences are noted in the intensity of accumulation possibly due to the isotope
differences as can be seen in the figure below (Figure 1). These data are not
sufficient to understand the different characteristics or determine equivalent accuracy
of the C11 and F18 drugs. We therefore propose acquiring sufficient data to help
characterize the two drugs. We will scan both AD and normal subjects to allow us to
understand the diagnostic accuracy of the two drugs.
2. Determine the relative differences in biodistribution of the PET agents and what
corrections could be made to allow for adjustments of the data obtained using C11 PiB
that will allow accurate comparisons with F18 Flutemetamol data in the same subjects.
If biodistribution differences in the two drugs are found, we will attempt to estimate
quantitative correction factors in the C11 images to help to data obtained from the
scans be comparable to future serial F18 Flutemetamol data.
3. Acquire FDG PET in the subjects to compare FDG PET imaging to PiB imaging.
Inclusion Criteria:
1. Males or females 30 years of age or older.
2. Subjects who have the clinical diagnosis of probable AD (30) ages 50 and older who
have a study partner who is the participant's power of attorney (POA) or legally
authorized representative (LAR), cognitive normal elderly (30) age >60 and cognitive
normal young subjects (30) ages 30-60.
3. Normal subjects with Clinical Dementia Rating (CDR) 0-0.5 and AD subjects with CDR of
0.5 or greater.
Exclusion Criteria:
1. Subjects unable to lie down without moving for 30 minutes.
2. Women who are pregnant or who cannot stop breast feeding for 24 hours.
3. Standard safety exclusionary criteria for MRI such as metallic foreign bodies,
pacemaker, etc,.
4. Subjects who are too claustrophobic to perform the tests.
5. Subject who have had previous brain irradiation, stroke or brain tumor(s)
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