Lactate Imaging as a Tumour Biomarker

January 27, 2020 updated by: Nandita deSouza, Institute of Cancer Research, United Kingdom

Investigation of Lactate Measured Using Magnetic Resonance Spectroscopy as a Biomarker of Tumour Response

This project is designed to investigate whether measurements of lactate in tumours, made using a magnetic resonance technique similar to MRI, is an effective non-invasive method to detect whether some new targeted drugs are having their desired effect.

The study hypothesis is that by using magnetic resonance spectroscopy techniques, we will be able to observe changes in tumour lactate levels in vivo, in response to treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

37

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • The Institute of Cancer Research and Royal Marsden NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Primary care clinic

Description

Inclusion Criteria:

Cohort 1:lymphoma patients

  • minimum lesion size of 2cm
  • not pretreated but scheduled to be treated with CHOP (Cyclophosphamide, Hydroxydaunomycin,Oncovin and Prednisolone)

Cohort 2:Colorectal patients

  • metastatic disease of at least 2cm
  • not pretreated

Cohort 3:Phase 1 Drug Development

  • minimum lesion size at least 2cm

Cohort 4: Brain

  • primary brain tumours receiving radiotherapy and temozolomide
  • cerebral lymphoma receiving standard chemotherapy

Exclusion Criteria:

  • MRI incompatible metal implants
  • Claustrophobia
  • Inability to tolerate a 40 minute MRI scan

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Lymphoma
Lymphoma patients before and after receiving standard CHOP therapy
Device: Magnetic Resonance Imaging (MRI)
Magnetic Resonance Spectroscopy
Metastatic Colorectal
Patients with metastatic colorectal cancer
Device: Magnetic Resonance Imaging (MRI)
Magnetic Resonance Spectroscopy
Phase 1
Patients enrolled in Phase 1 clinical trials of new agents, whose mechanism of action is expected to lead to changes in lactate concentration
Device: Magnetic Resonance Imaging (MRI)
Magnetic Resonance Spectroscopy
Brain
Patients with primary brain tumours and patients with cerebral lymphoma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Correlation between changes in MRS lactate measurements at two time points after treatment and clinical response
Time Frame: 7 and 21 days post treatment
7 and 21 days post treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Reproducibility of MRS lactate measurement
Time Frame: Two baseline measurements taken at day -7 to 0 pre-treatment
Two baseline measurements taken at day -7 to 0 pre-treatment

Other Outcome Measures

Outcome Measure
Time Frame
Correlation between changes in post treatment MRS lactate measurements and serum lactate dehydrogenase
Time Frame: Baseline and 7 and 21 days post treatment
Baseline and 7 and 21 days post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Cancer Research, United Kingdom

Collaborators

Cancer Research UK

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2013

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

June 17, 2013

First Submitted That Met QC Criteria

June 18, 2013

First Posted (Estimate)

June 19, 2013

Study Record Updates

Last Update Posted (Actual)

January 28, 2020

Last Update Submitted That Met QC Criteria

January 27, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 13/LO/0536 CCR3939

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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