Clinical trial · Interventional
Tissue Stresses of Cancer (Force Horizon 2020)
Tissue Stresses of Cancer: A Phase I/II,Multi-centre, Feasibility Study to Image the Tissue Stiffness/Stresses to Predict Outcome in Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Female | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRF scan | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- MRF +/-contrast enhanced MRI
- description
- MRF with or without contrast enhanced MRI
- interventionNames
- Other: MRF scan
Primary outcomes (1)
- measure
- Evidence of reduction in interstitial fluid pressure confirmed by MRF
- timeFrame
- up to 18 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDSinha AP, Jurrius P, van Schelt AS, Darwish O, Shifa B, Annio G, Peterson Z, Jeffery H, Welsh K, Metafa A, Spence J, Kothari A, Hamed H, Bitsakou G, Karydakis V, Thorat M, Shaari E, Sever A, Rigg A, Ng T, Pinder S, Sinkus R, Purushotham A. Tumor Biomechanics Quantified Using MR Elastography to Predict Response to Neoadjuvant Chemotherapy in Individuals with Breast Cancer. Radiol Imaging Cancer. 2025 Mar;7(2):e240138. doi: 10.1148/rycan.240138. PMID 39950962