Tissue Stresses of Cancer (Force Horizon 2020)

July 31, 2017 updated by: Guy's and St Thomas' NHS Foundation Trust

Tissue Stresses of Cancer: A Phase I/II,Multi-centre, Feasibility Study to Image the Tissue Stiffness/Stresses to Predict Outcome in Breast Cancer

This project is investigating a novel MRI method called Magnetic Resonance Force (MRF). MRF has been developed to accurately estimate tumour stiffness in the breast by measuring the interstitial fluid pressure (IFP).

50 healthy volunteers will be recruited to extend the hardware and establish MRF imaging acquisition protocols for pre and post-menopausal women. Once completed, we will test this new imaging technique with the acquired imaging protocols on 100 patients undergoing surgery as first line of their treatment for their breast cancer to establish a potential biomarker signature predictive of lymph node involvement and metastatic potential. Simultaneously, 50 patients undergoing chemotherapy as first line of their treatment for their breast cancers will be recruited to develop a biomarker signature that could predict response or resistance to neoadjuvant chemotherapy as determined by conventional imaging and histopathology.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Magnetic Resonance Force (MRF) is based on Magnetic Resonance Elastography which uses mechanical waves to quantitatively assess the viscoelastic properties of tumours and the shift in interstitial fluid pressure (or stiffness) of tissues.

It generates 3D images of applied deformation via low frequency acoustic waves within the tissue and provides a snapshot of the apparent stiffening of the tumour border zone. Growth induced stretch of the tumour not only increases stiffness but also alters the apparent change in stiffness due to additional loading. Magnetic Resonance Force (MRF) provides measures of MRE and macro-deformation at multiple load states therefore enabling estimation of tissue properties as well as the stress load relation. Since the stress load relation is related to tumour swelling and modifications, it can be directly linked to the tumour pre-strain and provides an indicator of the underlying interstitial tumour pressure. Using biomechanical models it is possible to directly translate the stress load relation into an estimate of IFP. The same approach also allows quantifying the active pull by cell traction forces (CTFs) coming from the tumour and exerted onto its surroundings. While that force is directed inwards, the force generated by the elevated interstitial fluid pressure (IFP) is directed outwards allowing separation of both effects from each other. These forces represent one of the biomarkers which we will quantify within the this project using MRF.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United Kingdom
      • London, United Kingdom, SE1 9RT
        • Recruiting
        • Guy's and St.Thomas' NHS Foundation Trust
        • Contact:
        • Sub-Investigator:
          • Ralph Sinkus
        • Sub-Investigator:
          • Keshthra Satchithananda
        • Sub-Investigator:
          • Sarah Willson
        • Sub-Investigator:
          • Anna Rigg
        • Sub-Investigator:
          • Tony Ng

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria for healthy Volunteers:

  • Healthy female pre- and post-menopausal volunteers ≥ 40 years of age

  • Pre-menopausal patients between the age of 40-55 years of age will have two scans:

    1. Between day 7- 15 of their menstrual cycle and
    2. Between day 21-28 of their menstrual cycle
  • Postmenopausal patients of 55 years and above will have one scan only.
  • No prior history of breast cancer
  • Written informed consent to participate in this study

Inclusion Criteria for patients undergoing primary surgery:

  • Females ≥ 18 years of age with a diagnosis of invasive breast cancer with tumour size of at least 5mm as determined by USS
  • Scheduled to undergo breast conserving surgery or mastectomy +/- sentinel lymph node biopsy or axillary lymph node dissection
  • Written informed consent to participate in this study.

Inclusion Criteria for patients undergoing neoadjuvant chemotherapy:

  • Females ≥ 18 years of age with a diagnosis of invasive breast cancer
  • Scheduled to undergo neoadjuvant systemic chemotherapy
  • Written informed consent to participate in this study.

Exclusion Criteria for healthy volunteers:

Contraindications for MRI such as:

  • cardiac pacemaker
  • metallic implants
  • major claustrophobia
  • pregnancy or breastfeeding
  • Inability to provide written informed consent

Exclusion Criteria for patient undergoing primary surgery and neoadjuvant chemotherapy:

  • Contraindications for MRI such as:
  • cardiac pacemaker
  • metallic implants
  • major claustrophobia
  • prior breast cancer treatment
  • pregnancy or breastfeeding
  • known allergy against the contrast agent (gadolinium chelate) and renal failure
  • Inability to provide written informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: MRF +/-contrast enhanced MRI
MRF with or without contrast enhanced MRI
Other: MRF scan
MRF with or without dynamic contrast-enhanced MRI scans.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Evidence of reduction in interstitial fluid pressure confirmed by MRF
Time Frame: up to 18 months
up to 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Guy's and St Thomas' NHS Foundation Trust

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
King's College London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 24, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 3, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 3, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 204546

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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