Lactate Imaging as a Tumour Biomarker

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Institute of Cancer Research, United Kingdom
Sponsor:
Collaborator:
Cancer Research UK
Information provided by (Responsible Party):
NdeSouza, Institute of Cancer Research, United Kingdom
ClinicalTrials.gov Identifier:
NCT01881386
First received: June 17, 2013
Last updated: June 9, 2014
Last verified: June 2014
  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 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reproducibility of MRS lactate measurement [ Time Frame: Two baseline measurements taken at day -7 to 0 pre-treatment ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: September 2013
Estimated Primary Completion Date: July 2016 (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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01881386

Contacts
Contact: Nandita deSouza, Professor 0208 661 3289 nandita.desouza@icr.ac.uk
Contact: Katherine May, BSc 0208 642 6011 ext 4109 katherine.may@rmh.nhs.uk

Locations
United Kingdom
The Institute of Cancer Research and Royal Marsden NHS Foundation Trust Recruiting
Sutton, Surrey, United Kingdom, SM2 5PT
Contact: Nandita deSouza, Professor    0208 661 3289    nandita.desouza@icr.ac.uk   
Contact: Katherine May, BSc    0208 661 3340    katherine.may@rmh.nhs.uk   
Sub-Investigator: Geoffrey Payne, PhD         
Sponsors and Collaborators
Institute of Cancer Research, United Kingdom
Cancer Research UK
Investigators
Principal Investigator: Nandita deSouza, Professor ICR
  More Information

No publications provided

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
Study First Received: June 17, 2013
Last Updated: June 9, 2014
Health Authority: United Kingdom: Research Ethics Committee

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

ClinicalTrials.gov processed this record on July 23, 2014