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NCT02317783 · ClinicalTrials.gov registry record · Phase 2
Amyloid Plaque Deposition in Chemotherapy-Induced Cognitive Impairment
A Phase 2 study, sponsored by University of Utah.
- Terminated
- Registry status
- Phase 2
- Development phase
- 15
- Enrollment target
NCT02317783: Clinical Trial Phase 2 study, sponsored by University of Utah.
NCT02317783 is a Phase 2 study that was terminated before completion, run by University of Utah. The registered enrollment target is 15 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02317783, a Phase 2 study, was terminated before completion, sponsored by University of Utah.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 15 participants
- Enrollment target
Study Summary
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 fMRI 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 fMRI 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 fMRI to study a poorly understood but common problem: cognitive impairment in breast cancer patients treated with chemotherapy. If \[18F\]Flutemetamol, FDG-PET, and fMRI
Primary Outcome
\[18F\]Flutemetamol uptake will be assessed by visual criteria according to the approved Vizamyl prescribing information. Scans will be assessed by a binary grade of positive or negative corresponding to abnormal \[18F\]Flutemetamol uptake.
Interventions
- DIAGNOSTIC_TEST Functional Magnetic Resonance Imaging (fMRI)
- DRUG [18F]fluoro-2-deoxy-D-glucose (FDG)
- DRUG [18F]Flutemetamol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2018-01-31 |
| Est. Completion | 2019-09-24 |
| Phase | Phase 2 |
Why NCT02317783 stopped before completion
NCT02317783 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 3 interventions - of which Functional Magnetic Resonance Imaging (fMRI) is the first listed.
NCT02317783 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02317783 about?
NCT02317783 is a clinical study titled "Amyloid Plaque Deposition in Chemotherapy-Induced Cognitive Impairment". 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: Explo...
What is the current status of trial NCT02317783?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2018-01-31. Estimated completion is 2019-09-24.
What interventions are being tested in trial NCT02317783?
The interventions under investigation include: Functional Magnetic Resonance Imaging (fMRI) (DIAGNOSTIC_TEST), [18F]fluoro-2-deoxy-D-glucose (FDG) (DRUG), [18F]Flutemetamol (DRUG).
Who is sponsoring clinical trial NCT02317783?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02317783's enrollment target sits among peer trials
15 1919th of 2000 higher than 60 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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