Hyperpolarised 13C-Pyruvate MRI Study

NCT03687645 | Unknown DMC

• 1 other identifier: 205839
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Metabolic changes related to disease are the precursor to anatomical changes in tissues. Currently the imaging methods routinely used in clinical practice look at the anatomical changes. Whilst these methods are very helpful in making clinical decisions, they are far from being perfect. Early disease can be missed because these methods are not sensitive enough and it is not clear whether disease is present or not. Additionally, it is also difficult to know whether disease it aggressive or non-aggressive. Hyperpolarised MRI is a new imaging tool that may allow addressing these deficiencies in current imaging technology. The process of hyperpolarisation allows the production of an injectable solution that can produce signal on a standard MRI scanner inferring information about the metabolism occurring at a particular location. This technology has only just become available for clinical use. The initial stages of evaluation require the investigators to refine and develop the new imaging protocols so that assessment can be made as to whether consistent results can be achieved. Additionally, refining the imaging protocol could also aid in identifying where the best potential future clinical use of this technology should be targeted. Within this application the investigators aim to try out hyperpolarised MRI in a number of different cancers and also see whether it is useful to assess cardiac metabolism. The investigators will be using 13C-labelled metabolites (for this study 13C- pyruvate) which will allow interrogation of glucose metabolism. The derangement of glucose metabolism is common to a number of disease processes.

Conditions

Cancer; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• Pyruvate to Lactate conversion following the injection of Hyperpolarised 13C- Pyruvate

  Following the injection of Hyperpolarised 13C- Pyruvate, the rate of conversion of pyruvate to lactate will be measured using the lactate spectral peak height to produce metabolic map. Such metabolic maps generate the first-in-human images of tumour metabolism in patients with prostate, renal, breast, lymphoma cancers and cardiac disease

  3 years

Secondary Outcomes (3)

• Pyruvate to Lactate conversion as an imaging biomarker

  3 years

• Correlation of Hyperpolarised 13C- Pyruvate MRI with genetic markers

  3 years

• Hyperpolarised 13C MRI as an imaging biomarker to assess response

  3 years

Study Arms (4)

Prostate Cancer

EXPERIMENTAL

Patients with biopsy-proven prostate cancer will be recruited for an additional Hyperpolarised MRI scan prior to any treatment

Diagnostic Test: Hyperpolarised MRI

Renal Cancer

EXPERIMENTAL

Patients with biopsy-proven renal cell carcinoma will be recruited for an additional Hyperpolarised MRI scan prior to any treatment

Diagnostic Test: Hyperpolarised MRI

Breast Cancer

EXPERIMENTAL

Patients with biopsy-proven breast cancer will be recruited for an additional Hyperpolarised MRI scan prior to any treatment

Diagnostic Test: Hyperpolarised MRI

Lymphoma

EXPERIMENTAL

Patients with biopsy-proven lymphoma will be recruited for an additional Hyperpolarised MRI scan prior to any treatment

Diagnostic Test: Hyperpolarised MRI

Interventions

Hyperpolarised MRI DIAGNOSTIC_TEST

Hyperpolarized (HP) 13C MR is an advanced imaging technique that allows monitoring of dynamic metabolic processes non-invasively. Hyperpolarisation is a process that provides dramatic gains in sensitivity (\>10,000) of MRI signal collected from 13C-labelled substrates that can be injected into living systems, allowing in-vivo metabolism for the first time to be observed in real-time using imaging.

Breast Cancer; Lymphoma; Prostate Cancer; Renal Cancer

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or over
• Suspected Prostate Cancer/Renal Cancer/Rectal Cancer/Pancreatic Cancer
• No current renal impairment or an eGFR within a standard reference value if there is a history of renal disease.
• Subject able to comply with study procedures and provide informed consent.
• Patient is willing to undergo MRI/Hyperpolarised 13C-Pyruvate MRI or with other nuclei and substrate (where appropriate).
• Eastern Cooperative Oncology Group Performance Status (ECOG) of 0 or 2

You may not qualify if:

• Contraindication to MRI (e.g cardiac pacemaker)
• Contraindication to MR contrast agents
• Pregnancy
• Breast Feeding
• Deranged renal function (eGFR\<30) -

Sponsors & Collaborators

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

Study Sites (1)

University College London

London, United Kingdom

RECRUITING

MeSH Terms

Conditions

Neoplasms; Cardiovascular Diseases

Study Officials

• Dr Shonit Punwani

  University College, London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr Shonit Punwani

CONTACT

00442035495663; shonit.punwani@nhs.net

Dr Arash Latifoltojar

CONTACT

00442035495663; arash.latifoltojar.10@ucl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 11, 2018
• First Posted: September 27, 2018
• Study Start: July 1, 2017
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: September 27, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)