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

June 17, 2013
June 9, 2014
September 2013
July 2016   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01881386 on ClinicalTrials.gov Archive Site
Reproducibility of MRS lactate measurement [ Time Frame: Two baseline measurements taken at day -7 to 0 pre-treatment ] [ Designated as safety issue: No ]
Same as current
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 ]
Same as current
 
Lactate Imaging as a Tumour Biomarker
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Primary care clinic

Cancer
Device: Magnetic Resonance Imaging (MRI)
Magnetic Resonance Spectroscopy
  • Lymphoma
    Lymphoma patients before and after receiving standard CHOP therapy
    Intervention: Device: Magnetic Resonance Imaging (MRI)
  • Metastatic Colorectal
    Patients with metastatic colorectal cancer
    Intervention: Device: Magnetic Resonance Imaging (MRI)
  • 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
    Intervention: Device: Magnetic Resonance Imaging (MRI)
  • Brain
    Patients with primary brain tumours and patients with cerebral lymphoma
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
Not Provided
July 2016   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
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
United Kingdom
 
NCT01881386
13/LO/0536 CCR3939
No
NdeSouza, Institute of Cancer Research, United Kingdom
Institute of Cancer Research, United Kingdom
Cancer Research UK
Principal Investigator: Nandita deSouza, Professor ICR
Institute of Cancer Research, United Kingdom
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP