- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03212157
GlucoCEST MRI in Oncology
Establishment of GlucoCEST MRI as a Biomarker in Cancer Translational Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The technique involves administration of glucose solution either orally or intravenously. This is metabolised and concentrated into the intracellular compartment rapidly, which can be detected by GlucoCEST MRI. The abnormally high glucose uptake demonstrated by certain tumours is therefore potential biomarkers. At present this is already being investigated in head and neck cancer patients using oral glucose in a separate study. In this proposal we aim to utilise intravenous administration of glucose, which has been shown in pre-clinical studies to improve GlucoCEST signal, and thus likely to increase the detectability of cancer.
This study aims to develop and assess GlucoCEST and other exchange-sensitive MRI measurements (denoted 'exchange-sensitive MRI' hereafter) using intravenous glucose in tumours and metastases, and evaluate its use as an imaging biomarker of tumour and treatment response. This project will:
- Establish an optimised bolus and infusion protocol of intravenous glucose to maximise exchange-sensitive MRI signal.
- Assess the reproducibility of exchange-sensitive MRI and initial proof-of-concept study in cancer patients
- Apply exchange-sensitive MRI in selected cancer types to assess its diagnostic and prognostic power.
The initial optimisation study involves investigating the optimal regime of intravenous glucose administration for obtaining the optimal exchange-sensitive MRI signal. The second stage will see exchange-sensitive MRI being applied to patients in different cancer groups to assess its ability for detecting cancer.
For the optimisation study, 20 healthy volunteers will be recruited. For the application study 80 patients (20 Hodgkin's lymphoma, 20 head and neck tumour, and 40 glioma) will be investigated. Most of these patients will be due for an MRI as part of their standard care pathway; in these cases exchange-sensitive MRI will be added to the standard imaging sequence. For those who are not otherwise due for MRI, both standard and exchange-sensitive MRI will be acquired.
It is expected that the data generated from this study will inform the design of larger trials and will provide the framework for an improved imaging pathway in certain cancer groups in the future.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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London, United Kingdom, NW1 2PG
- University College London Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Healthy Volunteers:
- No previous history of cancer
- No known renal impairment or an eGFR within a standard reference value if there is a history of renal disease.
- Aged 18 or over with capacity to consent.
Patient groups:
- Confirmed diagnosis of selected cancer types (head and neck, lymphoma and glioma)
- No known renal impairment or an eGFR within a standard reference value if there is a history of renal disease
- Aged 18 or over with capacity to consent.
Exclusion Criteria:
For both groups:
- Confirmed diagnosis of selected cancer types (head and neck, lymphoma and glioma)
- Pregnancy
- Contradiction to MRI magnetic field (pacemaker, metallic implant, severe claustrophobia, etc)
- Allergy to MR contrast agent (Gadolinium)
- Adult with Impaired capacity
- Deranged renal function with eGFR
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NON_RANDOMIZED
- Interventional Model: SEQUENTIAL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: GT1
Optimsation of glucose infusion protocol outside the Magnetic Resonance Imaging (MRI) scanner in healthy volunteers.
To establish an optimised bolus and safety of infusion protocol of intravenous glucose to maximise exchange sensitive MRI signal.
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Infusion of 20% dextrose (drug) and using this as an imaging tracer in detecting and staging tumours.
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EXPERIMENTAL: GT2
Optimsation of glucose infusion protocol inside the Magnetic Resonance Imaging (MRI) scanner in patient volunteers.
To assess the reproducibility of these techniques and initial proof-of-concept study in cancer patients
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Infusion of 20% dextrose (drug) and using this as an imaging tracer in detecting and staging tumours.
MRI scanners (device) use strong magnetic fields, radio waves, and field gradients to generate images of the organs in the body.
Specifically using the MRI scanner with the infusion of dextrose in detecting and staging tumours.
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EXPERIMENTAL: GT3
Use of glucoCEST technique in staging of head and neck SCC, lymphoma and gliomas and correlating diagnostic potential with standard imaging such as FDG PET.
To apply exchange-sensitive MRI in selected cancer types to assess its diagnostic potential.
To study of non-glucose endogenous exchange sensitive MRI signals in (a) Prostate Cancer and (b) high grade Glioma patients.
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Infusion of 20% dextrose (drug) and using this as an imaging tracer in detecting and staging tumours.
MRI scanners (device) use strong magnetic fields, radio waves, and field gradients to generate images of the organs in the body.
Specifically using the MRI scanner with the infusion of dextrose in detecting and staging tumours.
FDG is a sugar (glucose) labelled with a small amount of radioactivity which goes to parts of the body that use glucose for energy.
PET/CT images are acquired on a single scanner.
An FDG PET scan can be used to assess the presence, location and severity of cancers.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Developing new biochemical imaging tracer
Time Frame: 4 years
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Optimised exchange-sensitive MRI techniques using intravenous glucose.
Evaluation of the added value of quantitative GlucoCEST imaging, derived using OM CEST analysis software, to standard multi-modality anatomical imaging
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4 years
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Assessing diagnostic value of glucoCEST
Time Frame: 4 years
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Exchange-sensitive MRI in selected cancer types to assess its potential diagnostic value.
Pre-treatment and post-treatment quantitative GlucoCEST MRI will be evaluated for prediction of residual/recurrent disease against clinical outcome measures of DFS, TTP and OS.
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4 years
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13/0450
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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