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Lactate Imaging as a Tumour Biomarker

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01881386
First Posted: June 19, 2013
Last Update Posted: September 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Cancer Research UK
Information provided by (Responsible Party):
NdeSouza, Institute of Cancer Research, United Kingdom
  Purpose

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.


Condition Intervention
Cancer Device: Magnetic Resonance Imaging (MRI)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Investigation of Lactate Measured Using Magnetic Resonance Spectroscopy as a Biomarker of Tumour Response

Resource links provided by NLM:


Further study details as provided by NdeSouza, Institute of Cancer Research, United Kingdom:

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

Secondary Outcome Measures:
  • Reproducibility of MRS lactate measurement [ Time Frame: Two baseline measurements taken at day -7 to 0 pre-treatment ]

Other Outcome Measures:
  • Correlation between changes in post treatment MRS lactate measurements and serum lactate dehydrogenase [ Time Frame: Baseline and 7 and 21 days post treatment ]

Enrollment: 37
Actual Study Start Date: September 2013
Estimated Study Completion Date: September 2018
Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Primary care clinic
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01881386


Locations
United Kingdom
The Institute of Cancer Research and Royal Marsden NHS Foundation Trust
Sutton, Surrey, United Kingdom, SM2 5PT
Sponsors and Collaborators
Institute of Cancer Research, United Kingdom
Cancer Research UK
Investigators
Principal Investigator: Nandita deSouza, Professor ICR
  More Information

Responsible Party: NdeSouza, Professor of Translational Imaging, Institute of Cancer Research, United Kingdom
ClinicalTrials.gov Identifier: NCT01881386     History of Changes
Other Study ID Numbers: 13/LO/0536 CCR3939
First Submitted: June 17, 2013
First Posted: June 19, 2013
Last Update Posted: September 15, 2017
Last Verified: September 2017

Keywords provided by NdeSouza, Institute of Cancer Research, United Kingdom:
Magnetic Resonance Spectroscopy
Lactate