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Tissue Stresses of Cancer (Force Horizon 2020)

Primary Purpose

Breast Cancer Female

Status

Unknown status

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

MRF scan

About this trial

This is an interventional diagnostic trial for Breast Cancer Female

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Guy's and St.Thomas' NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

MRF +/-contrast enhanced MRI

Arm Description

MRF with or without contrast enhanced MRI

Outcomes

Primary Outcome Measures

Evidence of reduction in interstitial fluid pressure confirmed by MRF

Secondary Outcome Measures

Full Information

NCT ID

NCT03238144

First Posted

November 24, 2016

Last Updated

July 31, 2017

Sponsor

Guy's and St Thomas' NHS Foundation Trust

Collaborators

King's College London

1. Study Identification

Unique Protocol Identification Number

NCT03238144

Brief Title

Tissue Stresses of Cancer (Force Horizon 2020)

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Unknown status

Study Start Date

November 2016 (undefined)

Primary Completion Date

January 2019 (Anticipated)

Study Completion Date

December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Guy's and St Thomas' NHS Foundation Trust

Collaborators

King's College London

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer Female

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

MRF +/-contrast enhanced MRI

Arm Type

Other

Arm Description

MRF with or without contrast enhanced MRI

Intervention Type

Other

Intervention Name(s)

MRF scan

Intervention Description

MRF with or without dynamic contrast-enhanced MRI scans.

Primary Outcome Measure Information:

Title

Evidence of reduction in interstitial fluid pressure confirmed by MRF

Time Frame

up to 18 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: Between day 7- 15 of their menstrual cycle and 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Arnie Purushotham

Phone

0207 188 188

Ext

3027

ea-purushotham@kcl.ac.uk

First Name & Middle Initial & Last Name or Official Title & Degree

Sweta Sethi

Phone

02017 188 188

Ext

80743

sweta.sethi@gstt.nhs.uk

Facility Information:

Facility Name

Guy's and St.Thomas' NHS Foundation Trust

City

London

ZIP/Postal Code

SE1 9RT

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sweta Sethi

Phone

0207 188 188

Ext

80743

sweta.sethi@gstt.nhs.uk

First Name & Middle Initial & Last Name & Degree

Ralph Sinkus

First Name & Middle Initial & Last Name & Degree

Keshthra Satchithananda

First Name & Middle Initial & Last Name & Degree

Sarah Willson

First Name & Middle Initial & Last Name & Degree

Anna Rigg

First Name & Middle Initial & Last Name & Degree

Tony Ng

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Tissue Stresses of Cancer (Force Horizon 2020)

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