Clinical trial · Observational
MRI and Early Decision-making in Chemotherapy for Breast Cancer
Characterising Early Response to Neoadjuvant Chemotherapy With Quantitative Breast MRI
- 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)
Firstly, the investigators aim to show that breast tumour blood flow, measured as part of a standard MRI examination, decreases at the earliest stage of neoadjuvant chemotherapy in those patients who go on to respond to treatment. Importantly, the investigators will also show that blood flow does not decrease in those patients who fail to respond. Secondly, the investigators will test whether the decrease in tumour blood flow over the whole course of neoadjuvant chemotherapy can predict the response of the tumour measured at the time of surgery.
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 Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| magnetic resonance imaging | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- magnetic resonance imaging
- description
- Participants will undergo MRI at baseline, after 1 cycle, 3 cycles and at completion of neoadjuvant chemotherapy.
- interventionNames
- Other: magnetic resonance imaging
Primary outcomes (1)
- measure
- Change in tumour blood flow between baseline and after 1 cycle of neoadjuvant chemotherapy
- timeFrame
- 2 weeks
- description
- Cycle 1 length \~ 2 weeks.
Secondary outcomes (3)
- measure
- Rate of change in tumour blood flow measured at baseline, after 1 cycle, 3 cycles and 6 cycles of NAC & pathological response.
- timeFrame
- ~18 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Newly diagnosed large but operable invasive carcinoma of the breast. All molecular subtypes are eligible and incidentally detected small volume metastatic disease is NOT an exclusion criterion. * Clinical indication for NAC as determined by the Breast Therapeutic MDT. * Sufficient biopsy material taken at diagnosis to measure the standard molecular markers. * Participant is willing and able to give informed consent for participation in the study. * Female, aged 18 years or above. * Histologically or cytologically confirmed invasive carcinoma of the breast and having received no prior treatment for this. * Female participants of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study. * Participant has adequate renal function (estimated glomerular filtration rate ≥ 30 ml/min). * In the Investigator's opinion, is able and willing to comply with all study requirements. Exclusion Criteria: * Previous breast cancer treated with radiotherapy or chemotherapy or recurrent breast cancer. * Female participant who is pregnant, lactating or planning pregnancy during the course of the study. * Significant renal impairment (estimated glomerular filtration rate \< 30 ml/min). * Contraindication to MRI.
References
Publications (0)
Data not yet available