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
-
-
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
|
Magnetic Resonance Spectroscopy
|
|
Metastatic Colorectal
Patients with metastatic colorectal cancer
|
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
|
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.
Collaborators
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.