Head and Neck Squamous Cell CarcinomaNCT03212157
GlucoCEST MRI in Oncology
A study testing Glucose infusion, Magnetic Resonance Imaging (MRI) and FDG PET in people with Head and Neck Squamous Cell Carcinoma and Lymphoma, run by University College, London at 1 site in United Kingdom.
Trial summary
The roles of imaging in cancer may be divided into that of diagnosis and tumour detection, staging and assessment of response to treatment. Standard radiological techniques include ultrasound, Computed Tomography (CT), Magnetic Resonance Imaging (MRI) and Positron Emission Tomography (PET). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma, Lymphoma, Glioma
- What is being tested?
- Glucose infusion, Magnetic Resonance Imaging (MRI) and FDG PET
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Jan 2017to 8 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University College London Hospital
London, NW1 2PG
About this study
Official title: Establishment of GlucoCEST MRI as a Biomarker in Cancer Translational Study
The roles of imaging in cancer may be divided into that of diagnosis and tumour detection, staging and assessment of response to treatment. Standard radiological techniques include ultrasound, Computed Tomography (CT), Magnetic Resonance Imaging (MRI) and Positron Emission Tomography (PET). A combination of imaging techniques is often necessary to differentiate between cancerous and normal tissue. Traditional imaging techniques identify cancers by their gross appearance and structural/ cellular characteristics, whilst PET do so by tracking glucose metabolism. PET owes its specificity to the high rate of glucose metabolism seen in most cancers. However it is not used routinely due to a lack of availability and high costs. In addition, PET is often used in combination with CT, which imparts a significant diagnostic radiation dose. This can increase an individual's risk of cancer, especially with childhood or early adult exposure. In contrast, MRI is more readily available and does not involve radiation. However its ability to detect cancer by tracking glucose metabolism has not been widely explored. Our group has recently developed a novel MRI technique called Gluco-CEST that can image glucose delivery, uptake and metabolism in cancer, therefore potentially allowing a radiation-free, one-stop imaging service that can be adapted to current generation of MRI scanners. This study aims to optimise the GlucoCEST technique, after which it will be rigorously tested and compared to standard imaging parameters and clinical or pathological reference standards to evaluate its diagnostic and predictive power across a number of cancer populations.
Read the 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.
- Conditions
- Head and Neck Squamous Cell Carcinoma, Lymphoma, Glioma
- Being tested
- Glucose infusion, Magnetic Resonance Imaging (MRI), FDG PET
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Lymphoma, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucose infusionOther
Infusion of 20% dextrose (drug) and using this as an imaging tracer in detecting and staging tumours.
Magnetic Resonance Imaging (MRI)Diagnostic test
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 PETDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| GT1 | Experimental | 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. Receives: Other: Glucose infusion |
| GT2 | Experimental | 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 Receives: Other: Glucose infusion; Diagnostic Test: Magnetic Resonance Imaging (MRI) |
| GT3 | Experimental | 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. Receives: Other: Glucose infusion; Diagnostic Test: Magnetic Resonance Imaging (MRI); Diagnostic Test: FDG PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Developing new biochemical imaging tracer
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
Measured: 4 years
Assessing diagnostic value of glucoCEST
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.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start6 Jan 2017
- Primary completion1 Sep 2019
- Study completion8 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Research UK
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03212157
- Sponsor's protocol ID
- 13/0450
- Status last verified
- Sep 2021
- First submitted
- 27 Jun 2017
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Walker-Samuel S, Ramasawmy R, Torrealdea F, Rega M, Rajkumar V, Johnson SP, Richardson S, Goncalves M, Parkes HG, Arstad E, Thomas DL, Pedley RB, Lythgoe MF, Golay X. In vivo imaging of glucose uptake and metabolism in tumors. Nat Med. 2013 Aug;19(8):1067-72. doi: 10.1038/nm.3252. Epub 2013 Jul 7.
PubMed 23832090
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of GlucoCEST MRI as a Biomarker in Cancer Translational Study
- ClinicalTrials.gov ID
- NCT03212157
- Acronym / sponsor ID
- 13/0450
- Conditions
- Head and Neck Squamous Cell Carcinoma, Lymphoma, Glioma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- Cancer Research UK
- Study start
- 6 Jan 2017 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 8 Oct 2019 (actual)
- First posted
- 11 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The roles of imaging in cancer may be divided into that of diagnosis and tumour detection, staging and assessment of response to treatment. Standard radiological techniques include ultrasound, Computed Tomography (CT), Magnetic Resonance Imaging (MRI) and Positron Emission Tomography (PET). A combination of imaging techniques is often necessary to differentiate between cancerous and normal tissue. Traditional imaging techniques identify cancers by their gross appearance and structural/ cellular characteristics, whilst PET do so by tracking glucose metabolism. PET owes its specificity to the high rate of glucose metabolism seen in most cancers. However it is not used routinely due to a lack of availability and high costs. In addition, PET is often used in combination with CT, which imparts a significant diagnostic radiation dose. This can increase an individual's risk of cancer, especially with childhood or early adult exposure. In contrast, MRI is more readily available and does not involve radiation. However its ability to detect cancer by tracking glucose metabolism has not been widely explored. Our group has recently developed a novel MRI technique called Gluco-CEST that can image glucose delivery, uptake and metabolism in cancer, therefore potentially allowing a radiation-free, one-stop imaging service that can be adapted to current generation of MRI scanners. This study aims to optimise the GlucoCEST technique, after which it will be rigorously tested and compared to standard imaging parameters and clinical or pathological reference standards to evaluate its diagnostic and predictive power across a number of cancer populations.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GT1 | Experimental | Other: Glucose infusionOptimsation 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. |
| GT2 | Experimental | Other: Glucose infusion, Diagnostic Test: Magnetic Resonance Imaging (MRI)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 |
| GT3 | Experimental | Other: Glucose infusion, Diagnostic Test: Magnetic Resonance Imaging (MRI), Diagnostic Test: FDG PETUse 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Healthy Volunteers:
- Patient groups:
Key exclusion criteria (7 listed)
- For both groups:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glucose infusionInfusion of 20% dextrose (drug) and using this as an imaging tracer in detecting and staging tumours. | Other | GT1, GT2, GT3 |
| Magnetic Resonance Imaging (MRI)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. | Diagnostic test | GT2, GT3 |
| FDG PETFDG 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. | Diagnostic test | GT3 |
Primary outcome
Developing new biochemical imaging tracer
Time frame: 4 years
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
Assessing diagnostic value of glucoCEST
Time frame: 4 years
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
- Background: PubMed 23832090Walker-Samuel S, Ramasawmy R, Torrealdea F, Rega M, Rajkumar V, Johnson SP, Richardson S, Goncalves M, Parkes HG, Arstad E, Thomas DL, Pedley RB, Lythgoe MF, Golay X. In vivo imaging of glucose uptake and metabolism in tumors. Nat Med. 2013 Aug;19(8):1067-72. doi: 10.1038/nm.3252. Epub 2013 Jul 7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glucose infusion, Magnetic Resonance Imaging (MRI) and FDG PET in people with Head and Neck Squamous Cell Carcinoma and Lymphoma, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Developing new biochemical imaging tracer (time frame: 4 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03212157, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2021.