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Bridging Study of C11 Pittsburgh Compound B (PiB) and F18 Flutemetamol Brain Positron Emission Tomography (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: September 12, 2016
Last verified: August 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 Alzheimer's disease (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.

Condition Intervention Phase
Alzheimer's Disease
Drug: C11 PiB
Drug: F18 Flutametamol
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:
  • Global Distribution of C11 PiB in the Brain [ Time Frame: Approximately one hour after injection of positron emission tomography (PET) drug ] [ Designated as safety issue: No ]

    The imaging analysts use a global atlas of the brain to measure the uptake of the radioactive tracer (or brightness) globally. This global uptake was normalized to the uptake in the cerebellar crus region of the brain to get a global Standard Uptake Value Ratio (SUVR). The cerebral crus (crus cerebri) is the anterior portion of the cerebral peduncle which contains the motor tracts.

    The standard uptake value (SUV) is a way of determining activity in PET imaging. The SUVR is the ratio of SUV from two different regions within the same PET image. For the SUVR, the injected activity, the body weight and the volume to mass conversion factor that are all part of the SUV calculation, cancel.


  • Global Distribution of F18 Flutemetamol in the Brain [ Time Frame: Approximately one hour after injection of positron emission tomography (PET) drug ] [ Designated as safety issue: No ]

    The imaging analysts use a global atlas of the brain to measure the uptake of the radioactive tracer (or brightness) globally. This global uptake was normalized to the uptake in the cerebellar crus region of the brain to get a global Standard Uptake Value Ratio (SUVR). The cerebral crus (crus cerebri) is the anterior portion of the cerebral peduncle which contains the motor tracts.

    The standard uptake value (SUV) is a way of determining activity in PET imaging. The SUVR is the ratio of SUV from two different regions within the same PET image. For the SUVR, the injected activity, the body weight and the volume to mass conversion factor that are all part of the SUV calculation, cancel.



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 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.

Drug: C11 PiB
One time intravenous administration of 8-22 millicurie (mCi) C11 PiB
Other Names:
  • C11 PiB PET/CT
  • C11 Pittsburgh Compound B
Drug: F18 Flutametamol
One time intravenous administration of 3-7 mCi F18 Flutametamol.
Other Names:
  • F18 Flutametamol PET/CT
  • Vizamyl
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.
Drug: C11 PiB
One time intravenous administration of 8-22 millicurie (mCi) C11 PiB
Other Names:
  • C11 PiB PET/CT
  • C11 Pittsburgh Compound B
Drug: F18 Flutametamol
One time intravenous administration of 3-7 mCi F18 Flutametamol.
Other Names:
  • F18 Flutametamol PET/CT
  • Vizamyl
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.
Drug: C11 PiB
One time intravenous administration of 8-22 millicurie (mCi) C11 PiB
Other Names:
  • C11 PiB PET/CT
  • C11 Pittsburgh Compound B
Drug: F18 Flutametamol
One time intravenous administration of 3-7 mCi F18 Flutametamol.
Other Names:
  • F18 Flutametamol PET/CT
  • Vizamyl

Detailed Description:

Some of the current thinking in regards to the pathophysiology of AD involves the production of amyloid Beta protein (AB) by secretase processing of amyloid precursor protein (APP). While AB is thought to be toxic to neurons its role leading to AD pathogenesis, this is not without debate. In any case, it appears that AB forms amyloid plaques that are largely ubiquitous in AD. Neuronal cell death as a result of the disease is another clear pathophysiologic finding. Because of the importance of these findings in the development of AD, targeted therapies are being investigated to selectively inhibit AB production and/or manipulate amyloid load.

Positron emission tomography (PET) is a molecular imaging modality used to noninvasively measure functional processes of the body. A trace amount of a radiopharmaceutical is injected into a patient and the radiopharmaceutical will be taken up or localized in the body as a function of certain biological processes. The detectors of a PET scanner then measure the radiopharmaceutical distribution externally and the reconstructed PET images should represent the true distribution of the radiopharmaceutical within the body.

  Eligibility

Ages Eligible for Study:   30 Years and older   (Adult, Senior)
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
Results First Received: August 2, 2016
Last Updated: September 12, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: Undecided
Plan Description: This study was funded by an industrial partner (GE) and discussions with the company about sharing the data will be entertained after first publications.

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Corticosterone
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on December 02, 2016