NCT03238144

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2016

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

November 24, 2016

Completed
8 months until next milestone

First Posted

Study publicly available on registry

August 3, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

August 3, 2017

Status Verified

July 1, 2017

Enrollment Period

2.2 years

First QC Date

November 24, 2016

Last Update Submit

July 31, 2017

Conditions

Breast Cancer Female

Outcome Measures

Primary Outcomes (1)

  • Evidence of reduction in interstitial fluid pressure confirmed by MRF

    up to 18 months

Study Arms (1)

MRF +/-contrast enhanced MRI

OTHER

MRF with or without contrast enhanced MRI

Other: MRF scan

Interventions

MRF scanOTHER

MRF with or without dynamic contrast-enhanced MRI scans.

MRF +/-contrast enhanced MRI

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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.
  • 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.

You may not qualify if:

  • Contraindications for MRI such as:
  • cardiac pacemaker
  • metallic implants
  • major claustrophobia
  • pregnancy or breastfeeding
  • Inability to provide written informed consent
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guy's and St.Thomas' NHS Foundation Trust

London, SE1 9RT, United Kingdom

RECRUITING

Related Publications (1)

  • Sinha 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: 39950962DERIVED

Central Study Contacts

Arnie Purushotham

CONTACT

0207 188 188ea-purushotham@kcl.ac.uk

Sweta Sethi

CONTACT

02017 188 188sweta.sethi@gstt.nhs.uk

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2016

First Posted

August 3, 2017

Study Start

November 1, 2016

Primary Completion

January 1, 2019

Study Completion

December 1, 2019

Last Updated

August 3, 2017

Record last verified: 2017-07

Locations

GB(1)