Status:
UNKNOWN
Tissue Stresses of Cancer (Force Horizon 2020)
Lead Sponsor:
Guy's and St Thomas' NHS Foundation Trust
Collaborating Sponsors:
King's College London
Conditions:
Breast Cancer Female
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
PHASE2
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...
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 flu...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2019
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03238144
Start Date
November 1 2016
End Date
December 1 2019
Last Update
August 3 2017
Active Locations (1)
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1
Guy's and St.Thomas' NHS Foundation Trust
London, United Kingdom, SE1 9RT