GlucoCEST MRI in Oncology

NCT03212157 | Completed DMC

• 1 other identifier: 13/0450
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Head and Neck Squamous Cell Carcinoma; Lymphoma; Glioma

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  4 years

Study Arms (3)

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.

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

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.

Other: Glucose infusion; Diagnostic Test: Magnetic Resonance Imaging (MRI); Diagnostic Test: FDG PET

Interventions

Glucose infusion OTHER

Infusion of 20% dextrose (drug) and using this as an imaging tracer in detecting and staging tumours.

GT1; GT2; GT3

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.

GT2; GT3

FDG PET DIAGNOSTIC_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.

GT3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University College, London: lead
• Cancer Research UK: collaborator

Study Sites (1)

University College London Hospital

London, NW1 2PG, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 23832090 BACKGROUND

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Lymphoma; Glioma

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2017
• First Posted: July 11, 2017
• Study Start: January 6, 2017
• Primary Completion: September 1, 2019
• Study Completion: October 8, 2019
• Last Updated: September 29, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)