Bridging Study of C11 PiB and F18 Flutemetamol Brain PET

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Val Lowe, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01607476
First received: May 23, 2012
Last updated: March 9, 2016
Last verified: March 2016
  Purpose

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.


Condition Intervention Phase
Alzheimer's Disease
Drug: C11 PiB
Drug: F18 Flutametamol
Drug: FDG
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Bridging Study of C11 PiB and F18 Flutemetamol Brain PET

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Distribution of C11 PiB and F18 Flutemetamol to areas of amyloid deposition in the brain. [ Time Frame: Subjects will be in the study for up to 90 days. ] [ Designated as safety issue: No ]

Enrollment: 89
Study Start Date: July 2012
Study Completion Date: March 2016
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Alzheimer's Disease

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).

Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT, FDG PET/CT.

Drug: C11 PiB
One time intravenous administration of 8-22 mCi C11 PiB
Other Name: C11 PiB PET/CT
Drug: F18 Flutametamol
One time intravenous administration of 3-7 mCi F18 Flutametamol.
Other Name: F18 Flutametamol PET/CT
Drug: FDG
One time intravenous administration of 10 mCi (+/- 20%) FDG.
Other Name: FDG PET/CT
Active Comparator: Cognitive Normal Elderly
Cognitive Normal subjects who are greater than 60 years of age. Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT, FDG PET/CT.
Drug: C11 PiB
One time intravenous administration of 8-22 mCi C11 PiB
Other Name: C11 PiB PET/CT
Drug: F18 Flutametamol
One time intravenous administration of 3-7 mCi F18 Flutametamol.
Other Name: F18 Flutametamol PET/CT
Drug: FDG
One time intravenous administration of 10 mCi (+/- 20%) FDG.
Other Name: FDG PET/CT
Active Comparator: Cognitive Normal Young
Cognitively normal subjects who are between 30-60 years old. Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT, FDG PET/CT.
Drug: C11 PiB
One time intravenous administration of 8-22 mCi C11 PiB
Other Name: C11 PiB PET/CT
Drug: F18 Flutametamol
One time intravenous administration of 3-7 mCi F18 Flutametamol.
Other Name: F18 Flutametamol PET/CT
Drug: FDG
One time intravenous administration of 10 mCi (+/- 20%) FDG.
Other Name: FDG PET/CT

Detailed Description:

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.
  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01607476

Locations
United States, Minnesota
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Val Lowe, MD Mayo Clinic
  More Information

Responsible Party: Val Lowe, Consultant - Diagnostic Radiology, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01607476     History of Changes
Other Study ID Numbers: 12-000118 
Study First Received: May 23, 2012
Last Updated: March 9, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies

ClinicalTrials.gov processed this record on May 04, 2016