Lactate Imaging as a Tumour Biomarker | NCT01881386

Studies
Lactate Imaging as a Tumour Biomarker

NCT01881386

Sponsor

Institute of Cancer Research, United Kingdom

Status

Completed

Last Update Posted

Jan 28, 2020Actual

Enrollment

37Actual

Phase

Not provided

Conditions

Cancer

Interventions

Magnetic Resonance Imaging (MRI)

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2013Actual

Primary Completion Date

Sep 1, 2017Actual

Completion Date

Sep 1, 2017Actual

First Submitted Date

Jun 17, 2013

First Submission Date that Met QC Criteria

Jun 18, 2013

First Posted Date

Jun 19, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 27, 2020

Last Update Posted Date

Jan 28, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Nandita deSouza, Professor of Translational Imaging, Institute of Cancer Research, United KingdomPrincipal Investigator

Lead Sponsor

Institute of Cancer Research, United KingdomOTHER

Collaborators

Name	Class
Cancer Research UK	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

37Actual

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
Lymphoma	Lymphoma patients before and after receiving standard CHOP therapy	Device: Magnetic Resonance Imaging (MRI)
Metastatic Colorectal	Patients with metastatic colorectal cancer	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	Device: Magnetic Resonance Imaging (MRI)
Brain	Patients with primary brain tumours and patients with cerebral lymphoma

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Magnetic Resonance Imaging (MRI)	Device	Magnetic Resonance Spectroscopy	Lymphoma Metastatic Colorectal Phase 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Correlation between changes in MRS lactate measurements at two time points after treatment and clinical response		7 and 21 days post treatment

Secondary Outcomes

Measure	Description	Time Frame
Reproducibility of MRS lactate measurement		Two baseline measurements taken at day -7 to 0 pre-treatment

Other Outcomes

Measure	Description	Time Frame
Correlation between changes in post treatment MRS lactate measurements and serum lactate dehydrogenase		Baseline and 7 and 21 days post treatment

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Primary care clinic

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nandita deSouza, Professor	ICR	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Institute of Cancer Research and Royal Marsden NHS Foundation Trust		Sutton	Surrey	SM2 5PT	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008279	Magnetic Resonance Imaging

Ancestor Terms

ID	Term
D014054	Tomography
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided