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
Sponsored by
About this trial
This is an interventional diagnostic trial for Breast Cancer Female
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
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
No
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
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
Email
ea-purushotham@kcl.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Sweta Sethi
Phone
02017 188 188
Ext
80743
Email
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
Email
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
Learn more about this trial
Tissue Stresses of Cancer (Force Horizon 2020)
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