Lactate Imaging as a Tumour Biomarker

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01881386
• Other study ID #: 13/LO/0536 CCR3939
• Status: Completed
• Start date: September 1, 2013
• Est. completion date: September 1, 2017

Study information

• Verified date: January 2020
• Source: Institute of Cancer Research, United Kingdom
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: September 1, 2017
• Est. primary completion date: September 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

Device:
• Magnetic Resonance Imaging (MRI)
Magnetic Resonance Spectroscopy

Locations

Country	Name	City	State
United Kingdom	The Institute of Cancer Research and Royal Marsden NHS Foundation Trust	Sutton	Surrey

Sponsors (2)

Lead Sponsor	Collaborator
Institute of Cancer Research, United Kingdom	Cancer Research UK

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Correlation between changes in post treatment MRS lactate measurements and serum lactate dehydrogenase		Baseline and 7 and 21 days post treatment
Primary	Correlation between changes in MRS lactate measurements at two time points after treatment and clinical response		7 and 21 days post treatment
Secondary	Reproducibility of MRS lactate measurement		Two baseline measurements taken at day -7 to 0 pre-treatment