Lactate Imaging as a Tumour Biomarker
Investigation of Lactate Measured Using Magnetic Resonance Spectroscopy as a Biomarker of Tumour Response
1 other identifier
observational
37
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2013
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 17, 2013
CompletedFirst Posted
Study publicly available on registry
June 19, 2013
CompletedStudy Start
First participant enrolled
September 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedJanuary 28, 2020
January 1, 2020
4 years
June 17, 2013
January 27, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Correlation between changes in MRS lactate measurements at two time points after treatment and clinical response
7 and 21 days post treatment
Secondary Outcomes (1)
Reproducibility of MRS lactate measurement
Two baseline measurements taken at day -7 to 0 pre-treatment
Other Outcomes (1)
Correlation between changes in post treatment MRS lactate measurements and serum lactate dehydrogenase
Baseline and 7 and 21 days post treatment
Study Arms (4)
Lymphoma
Lymphoma patients before and after receiving standard CHOP therapy
Metastatic Colorectal
Patients with metastatic colorectal cancer
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
Brain
Patients with primary brain tumours and patients with cerebral lymphoma
Interventions
Magnetic Resonance Spectroscopy
Eligibility Criteria
Primary care clinic
You may qualify if:
- 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
You may not qualify if:
- MRI incompatible metal implants
- Claustrophobia
- Inability to tolerate a 40 minute MRI scan
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Institute of Cancer Research, United Kingdomlead
- Cancer Research UKcollaborator
Study Sites (1)
The Institute of Cancer Research and Royal Marsden NHS Foundation Trust
Sutton, Surrey, SM2 5PT, United Kingdom
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nandita deSouza, Professor
ICR
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Translational Imaging
Study Record Dates
First Submitted
June 17, 2013
First Posted
June 19, 2013
Study Start
September 1, 2013
Primary Completion
September 1, 2017
Study Completion
September 1, 2017
Last Updated
January 28, 2020
Record last verified: 2020-01