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Efficacy of advanced semi-automated functional magnetic resonance (MR) imaging in the early prediction of response of locally advanced breast cancer to neoadjuvant chemotherapy

Establishing the efficacy of advanced semi-automated functional magnetic resonance (MR) imaging in the early prediction of response of locally advanced breast cancer to neoadjuvant chemotherapy: a pilot study

Status
Active, not recruiting
Phases
Phase 2
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN42613663
Enrollment
50
Registered
2009-06-17
Start date
2009-06-01
Completion date
Unknown
Last updated
2022-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer Cancer Malignant neoplasm of the breast

Interventions

The trial is anticipated to have an active recruitment period of 14 months. Patients will receive MRI scans at baseline (pre-commencement of chemotherapy), 4 - 7 days after commencement of their first

Sponsors

Hull and East Yorkshire NHS Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Provide written informed consent 2. Female 3. Aged 18 years or over 4. Newly diagnosed, histologically proven breast cancer (TNM stage T2- T4B, N0-3C, and M0) 5. Undergone both x-ray mammography and breast ultrasound scanning during the current treatment episode 6. Scheduled for neo-adjuvant chemotherapy

Exclusion criteria

Exclusion criteria: 1. Are medically unstable 2. Previously undergone chemotherapy 3. Have had surgery or radiotherapy for cancer in the ipsilateral breast 4. Have had surgery to the ipsilateral breast within the previous 4 months for benign breast disease 5. Have a history of serious breast trauma within the last 3 months 6. Are pregnant or breast feeding 7. Have renal failure 8. Fail the normal safety requirements of MR, particularly pacemakers and cardiac defibrillators 9. Are known to have had an allergic reaction associated with previous administration of a paramagnetic contrast agent 10. Have a known contraindication to MR scanning 11. Have a disability preventing MR scanning in the prone position 12. Have body habitus incompatible with MR system entry

Design outcomes

Primary

MeasureTime frame
1. The technical feasibility of using MR imaging in a multicentre setting using the most commonly available MR systems (i.e. is the trial able to scan patients to a specific protocol, using different types of MRI machine) 2. How reliably the imaging data can be analysed in a centralised, semi-automated, manner (i.e. can MRI data be reliably transferred from different centres and analysed using software based in the Centre for MR Investigations at the University of Hull)

Secondary

MeasureTime frame
No secondary outcome measures

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026