CancerNCT01881386
Lactate Imaging as a Tumour Biomarker
An observational study of Cancer, run by Institute of Cancer Research, United Kingdom at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cancer
- What is being tested?
- Magnetic Resonance Imaging (MRI)
- Type of treatment
- Medical device
- How many people
- 37 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2013to 1 Sep 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care clinic
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- MRI incompatible metal implants
- Claustrophobia
- Inability to tolerate a 40 minute MRI scan
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Institute of Cancer Research and Royal Marsden NHS Foundation Trust
Sutton, Surrey, SM2 5PT
About this study
Official title: 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.
- Conditions
- Cancer
- Being tested
- Magnetic Resonance Imaging (MRI)
- Keywords
- Magnetic Resonance Spectroscopy, Lactate
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance Imaging (MRI)Device
Magnetic Resonance Spectroscopy
| Study group | Role | What they receive |
|---|---|---|
| Lymphoma | Lymphoma patients before and after receiving standard CHOP therapy Receives: Device: Magnetic Resonance Imaging (MRI) | |
| Metastatic Colorectal | Patients with metastatic colorectal cancer Receives: 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 Receives: Device: Magnetic Resonance Imaging (MRI) | |
| Brain | Patients with primary brain tumours and patients with cerebral lymphoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between changes in MRS lactate measurements at two time points after treatment and clinical response
Measured: 7 and 21 days post treatment
Secondary outcomes (1)
Reproducibility of MRS lactate measurement
Measured: Two baseline measurements taken at day -7 to 0 pre-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2013 (estimated)
- Study start1 Sep 2013
- Primary completion1 Sep 2017
- Study completion1 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Cancer Research, United Kingdom
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Research UK
- Responsible party
- Principal investigator, Nandita deSouza, Institute of Cancer Research, United Kingdom
- Investigators
- Nandita deSouza, Professor, Principal investigator, ICR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01881386
- Sponsor's protocol ID
- 13/LO/0536 CCR3939
- Status last verified
- Jan 2020
- First submitted
- 17 Jun 2013
- Last updated
- 28 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Lactate Measured Using Magnetic Resonance Spectroscopy as a Biomarker of Tumour Response
- ClinicalTrials.gov ID
- NCT01881386
- Acronym / sponsor ID
- 13/LO/0536 CCR3939
- Conditions
- Cancer
- Keywords
- Magnetic Resonance Spectroscopy, Lactate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Institute of Cancer Research, United KingdomUniversity, hospital or other
- Collaborators
- Cancer Research UK
- Study start
- 1 Sep 2013 (actual)
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- 1 Sep 2017 (actual)
- First posted
- 19 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Lymphoma | – | Device: Magnetic Resonance Imaging (MRI)Lymphoma patients before and after receiving standard CHOP therapy |
| Metastatic Colorectal | – | Device: Magnetic Resonance Imaging (MRI)Patients with metastatic colorectal cancer |
| Phase 1 | – | Device: Magnetic Resonance Imaging (MRI)Patients enrolled in Phase 1 clinical trials of new agents, whose mechanism of action is expected to lead to changes in lactate concentration |
| Brain | – | –Patients with primary brain tumours and patients with cerebral lymphoma |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (3 listed)
- MRI incompatible metal implants
- Claustrophobia
- Inability to tolerate a 40 minute MRI scan
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance Imaging (MRI)Magnetic Resonance Spectroscopy | Device | Lymphoma, Metastatic Colorectal, Phase 1 |
Primary outcome
Correlation between changes in MRS lactate measurements at two time points after treatment and clinical response
Time frame: 7 and 21 days post treatment
1 secondary outcome
Reproducibility of MRS lactate measurement
Time frame: Two baseline measurements taken at day -7 to 0 pre-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nandita deSouza, Professor principal investigator
ICR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Institute of Cancer Research, United Kingdom at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2020.