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Last Updated: June 10, 2023

CLINICAL TRIALS PROFILE FOR VIZAMYL


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All Clinical Trials for Vizamyl

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01607476 ↗ Bridging Study of C11 Pittsburgh Compound B (PiB) and F18 Flutemetamol Brain Positron Emission Tomography (PET) Completed Mayo Clinic Phase 2 2012-07-01 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.
NCT02317783 ↗ Amyloid Plaque Deposition in Chemotherapy-Induced Cognitive Impairment Recruiting University of Utah Phase 2 2018-01-31 The initial goal of the investigators interdisciplinary group of imagers, oncologists, neurologists, neuro-psychologists, and biostatisticians is to obtain proof of concept pilot data for eventual submission of a National Cancer Institute Quick-Trial for Imaging and Image-Guided Interventions: Exploratory Grant (R10) depending on the results of this pilot study. The overall objective is to use [18F]Flutemetamol, FDG-PET, and MRI to better understand CICI, which effects up to 16 -50% of individuals receiving long-term adjuvant chemotherapy.2,3 To date there have been few studies examining this problem using multi-modality imaging techniques to better understand this complex and significant problem. FDG-PET and MRI are routinely used in clinical practice for the evaluation of cognitive dysfunction in older populations complaining of memory dysfunction. It is well recognized that FDG-PET can assist with the differentiation and characterization of various cognitive disorders due to unique patterns of cerebral metabolism caused by various cognitive and dementia-causing disorders.4-6 FDG-PET has been studied extensively in dementia research and has a high reliability in detecting Alzheimers disease (AD) many years before it can be diagnosed reliably using clinical criteria.4 To the investigators knowledge, there has been only a single small study using FDG-PET and bolus water activation paradigms in cancer patients complaining of memory problems.7 To date, there have been no studies using [18F]Flutemetamol as a PET imaging agent to assess the possibility of increased amyloid plaque burden as a potential contributing factor to the cognitive deficits and complaints seen in patients experiencing CICI. The novel feature of this project is in the combined use of [18F]Flutemetamol-PET, FDG-PET, and anatomic MRI to study a poorly understood but common problem: cognitive impairment in breast cancer patients treated with chemotherapy. If [18F]Flutemetamol, FDG-PET, and MRI can provide information on the pathophysiology of this disorder, it will be an important step in better understanding the etiology of this phenomenon and possibly other conditions resulting in cognitive dysfunction. These imaging assessments will make it possible to explore any altered changes in cerebral structure, metabolism, and amyloid deposition that may be responsible for CICI. This may help to predict which individuals may be affected by this problem and provide information for eventual therapeutic strategies to treat this common cancer-associated disorder. This study will use [18F]Flutemetamol and FDG-PET imaging to assess and quantify the amyloid plaque burden and cerebral glucose metabolism, respectively, in breast cancer patients suffering from CICI and correlate those findings with structural changes on MRI. The [18F]Flutemetamol and FDG-PET scans of these study patients will then be compared to two GE software databases (CortexID-FDG and CortexID-Flutemetamol) which contain scan data from healthy control individuals to evaluate for abnormalities in cerebral glucose metabolism and amyloid plaque burden differing from the values expected for individuals in their age range.
NCT02353949 ↗ Investigating the Clinical Consequences of Flutemetamol-PET-scanning Terminated ETH Zurich Phase 3 2015-05-01 The study examines subjects where there might be an indication for Amyloid-PET according to the Criteria defined by the Amyloid Imaging Task Force. In these subjects the impact of a Flutemetamol (Vizamyl)-Positron-Emission-Tomography -Scan (PET) on clinical management and disease course will be studied over 6 months.
NCT02353949 ↗ Investigating the Clinical Consequences of Flutemetamol-PET-scanning Terminated University of Zurich Phase 3 2015-05-01 The study examines subjects where there might be an indication for Amyloid-PET according to the Criteria defined by the Amyloid Imaging Task Force. In these subjects the impact of a Flutemetamol (Vizamyl)-Positron-Emission-Tomography -Scan (PET) on clinical management and disease course will be studied over 6 months.
NCT02778971 ↗ Implications for Management of PET Amyloid Classification Technology Recruiting University of Utah 2016-06-01 The main purpose of this study is to explore the impact of an amyloid positron emission tomography and computed tomography (PET/CT) scan on physician diagnosis and management, including drug management and care practices, for patients with a diagnosis of cognitive impairment. This study also intends to capture specific patient-reported outcomes related to patient burden, confidence and satisfaction. The hypothesis is that to aid early diagnosis, individuals with a diagnostically uncertain etiology for their dementia will benefit from knowledge of amyloid plaque burden status, through an alteration of patient diagnosis and management, which will lead to significant changes in patient and care partner reported outcomes.
NCT03232632 ↗ Assessment of Cardiac Fixation During PET Using a New Drug Within Amyloid Cardiac Injuries. Terminated University Hospital, Toulouse Early Phase 1 2017-03-15 To estimate distribution's parameters of 18F-Flutemetamol (Vizamyl┬«) fixation on myocardium for patients with amyloid cardiac injuries.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Vizamyl

Condition Name

Condition Name for Vizamyl
Intervention Trials
Alzheimer's Disease 3
Dementia 2
Mild Cognitive Impairment 2
Breast Cancer 1
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Condition MeSH

Condition MeSH for Vizamyl
Intervention Trials
Cognitive Dysfunction 3
Cognition Disorders 3
Alzheimer Disease 3
Dementia 2
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Clinical Trial Locations for Vizamyl

Trials by Country

Trials by Country for Vizamyl
Location Trials
United States 3
Switzerland 2
France 1
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Trials by US State

Trials by US State for Vizamyl
Location Trials
Utah 2
Minnesota 1
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Clinical Trial Progress for Vizamyl

Clinical Trial Phase

Clinical Trial Phase for Vizamyl
Clinical Trial Phase Trials
Phase 3 1
Phase 2 2
Phase 1 1
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Clinical Trial Status

Clinical Trial Status for Vizamyl
Clinical Trial Phase Trials
Terminated 2
Recruiting 2
Completed 1
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Clinical Trial Sponsors for Vizamyl

Sponsor Name

Sponsor Name for Vizamyl
Sponsor Trials
University of Utah 2
University of Zurich 1
University Hospital, Toulouse 1
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Sponsor Type

Sponsor Type for Vizamyl
Sponsor Trials
Other 7
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