Lactate Imaging as a Tumour Biomarker

NCT ID: NCT01881386

Last Updated: 2020-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

37 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-09-01

Study Completion Date

2017-09-01

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Lymphoma

Lymphoma patients before and after receiving standard CHOP therapy

Magnetic Resonance Imaging (MRI)

Intervention Type DEVICE

Magnetic Resonance Spectroscopy

Metastatic Colorectal

Patients with metastatic colorectal cancer

Magnetic Resonance Imaging (MRI)

Intervention Type DEVICE

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

Magnetic Resonance Imaging (MRI)

Intervention Type DEVICE

Magnetic Resonance Spectroscopy

Brain

Patients with primary brain tumours and patients with cerebral lymphoma

No interventions assigned to this group

Interventions

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Magnetic Resonance Imaging (MRI)

Magnetic Resonance Spectroscopy

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cancer Research UK

OTHER

Sponsor Role collaborator

Institute of Cancer Research, United Kingdom

OTHER

Sponsor Role lead

Responsible Party

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Nandita deSouza

Professor of Translational Imaging

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nandita deSouza, Professor

Role: PRINCIPAL_INVESTIGATOR

ICR

Locations

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The Institute of Cancer Research and Royal Marsden NHS Foundation Trust

Sutton, Surrey, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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13/LO/0536 CCR3939

Identifier Type: -

Identifier Source: org_study_id

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