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OpenTrials
Completed

NCT Number: NCT01881386

Lactate Imaging as a Tumour Biomarker

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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Institute of Cancer Research and Royal Marsden NHS Foundation Trust

Sutton, Surrey, SM2 5PT, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnetic Resonance Imaging (MRI)

Device

Magnetic Resonance Spectroscopy

Primary outcomes

  1. 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 outcomes

  1. Reproducibility of MRS lactate measurement

    Time frame: 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

    Time frame: Baseline and 7 and 21 days post treatment

Sponsors and collaborators

Lead sponsor

Institute of Cancer Research, United Kingdom

Other

Collaborators

  • Cancer Research UK

Registry information

Official study title

Investigation of Lactate Measured Using Magnetic Resonance Spectroscopy as a Biomarker of Tumour Response

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Jun 19, 2013
Registry last updated
Jan 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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