Bridging Study of C11 Pittsburgh Compound B (PiB) and F18 Flutemetamol Brain Positron Emission Tomography (PET)
Bridging Study of C11 PiB and F18 Flutemetamol Brain PET
1 other identifier
interventional
89
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2012
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 23, 2012
CompletedFirst Posted
Study publicly available on registry
May 30, 2012
CompletedStudy Start
First participant enrolled
July 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedResults Posted
Study results publicly available
November 1, 2016
CompletedApril 18, 2017
November 1, 2016
2.4 years
May 23, 2012
August 2, 2016
March 21, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Global Distribution of C11 PiB in the Brain
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.
Approximately one hour after injection of positron emission tomography (PET) drug
Global Distribution of F18 Flutemetamol in the Brain
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.
Approximately one hour after injection of positron emission tomography (PET) drug
Study Arms (3)
Alzheimer's Disease
EXPERIMENTALSubjects 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 and F-18 Flutametamol PET/CT with C11 PiB PET/CT performed first.
Cognitive Normal Elderly
ACTIVE COMPARATORCognitive Normal subjects who are greater than 60 years of age. Interventions include C11 PiB PET/CT and F-18 Flutametamol PET/CT with C11 PiB PET/CT performed first.
Cognitive Normal Young
ACTIVE COMPARATORCognitively normal subjects who are between 30-60 years old. Interventions include C11 PiB PET/CT and F-18 Flutametamol PET/CT with C11 PiB PET/CT performed first.
Interventions
One time intravenous administration of 8-22 millicurie (mCi) C11 PiB
One time intravenous administration of 3-7 mCi F18 Flutametamol.
Eligibility Criteria
You may qualify if:
- Males or females 30 years of age or older.
- 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.
- Normal subjects with Clinical Dementia Rating (CDR) 0-0.5 and AD subjects with CDR of 0.5 or greater.
You may not qualify if:
- Subjects unable to lie down without moving for 30 minutes.
- Women who are pregnant or who cannot stop breast feeding for 24 hours.
- Subjects who are too claustrophobic to perform the tests.
- Subject who have had previous brain irradiation, stroke or brain tumor(s)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic Rochester
Rochester, Minnesota, 55905, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Val Lowe
- Organization
- Mayo Clinic
Study Officials
- PRINCIPAL INVESTIGATOR
Val Lowe, MD
Mayo Clinic
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant - Diagnostic Radiology
Study Record Dates
First Submitted
May 23, 2012
First Posted
May 30, 2012
Study Start
July 1, 2012
Primary Completion
December 1, 2014
Study Completion
March 1, 2016
Last Updated
April 18, 2017
Results First Posted
November 1, 2016
Record last verified: 2016-11