Tissue Stresses of Cancer (Force Horizon 2020)

Phase 1

• Conditions: Breast Cancer Female
• Interventions: Other: MRF scan

• Registration Number: NCT03238144
• Lead Sponsor: Guy's and St Thomas' NHS Foundation Trust

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.

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2016-11-24
• Status Verified: 2017-07
• Study First Submitted QC: 2017-07-31
• Last Update Submitted: 2017-07-31
• Study First Posted: 2017-08-03
• Last Update Posted: 2017-08-03
• Primary Completion: 2019-01
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MRF +/-contrast enhanced MRI	MRF scan	MRF with or without contrast enhanced MRI

Primary Outcome Measures

Name	Time	Method
Evidence of reduction in interstitial fluid pressure confirmed by MRF	up to 18 months

Trial Locations

Locations (1)

Guy's and St.Thomas' NHS Foundation Trust; 🇬🇧 London, United Kingdom