High-resolution contrast-enhanced ultrasound and biological markers to assess the response of triple-negative breast cancer during neoadjuvant chemotherapy

Imaging of tumour microvasculature using high-resolution contrast-enhanced ultrasound together with markers of proliferation/angiogenesis/vascular mimicry to characterise the response to neoadjuvant chemotherapy in triple-negative breast cancer

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN85986368

Enrollment

Registered

2023-05-09

Start date

2022-10-11

Completion date

Unknown

Last updated

2023-05-22

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

Conditions

Triple-negative breast cancer (TNBC) Cancer Malignant neoplasm of breast

Interventions

High-resolution CEUS will be performed using an intravenous contrast agent to quantify tumor size and microvessel density and will be compared to conventional imaging techniques at three designated po

1) prior to NACT, 2) between cycles 2 & 3 of NACT and 3) upon completion of NACT. At two separate timepoints (diagnosis & between cycles 2 & 3) each patient will have 11G core biopsies of the tumour w

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Provision of written informed consent 2. Biologically female aged 18 to 60 years 3. Histologically confirmed TNBC with planned NACT 4. In the investigator's opinion, adhering to the trial recommendations and governance

Exclusion criteria

Exclusion criteria: 1. Cannot provide consent 2. Previous ipsilateral breast cancer with chemotherapy 3. Pregnant or breastfeeding 4. Locally advanced or inflammatory breast cancer 5. Metastatic breast cancer 6. Allergy to ultrasound contrast 7. TNBC subtype associated with good prognosis (adenoid cystic carcinoma, secretory carcinoma, acinic cell carcinoma, carcinoma with apocrine differentiation, low-grade metaplastic carcinoma and carcinoma arising in micro glandular adenosis) 8. Right to left cardiac shunt 9. Uncontrolled hypertension 10. Severe pulmonary hypertension 11. Recent thromboembolism 12. Hypercoagulation disorder 13. Adult respiratory distress syndrome

Design outcomes

Primary

Measure	Time frame
1. Imaging parameters (tumour vascularity, flow velocity and distribution, complexity of vascular structures [fractal dimension], regularity of vascular flow and vessel pulsatility) assessed using the high-resolution CEUS test and compared with the results of standard imaging prior to NACT, between cycles 2 & 3 of NACT and upon completion of NACT 2. Immunohistochemical markers of angiogenesis, proliferation and vascular mimicry measured using standard immunohistochemistry techniques prior to NACT, between cycles 2 & 3 of NACT and upon completion of NACT	—

Measure

Time frame

1. Imaging parameters (tumour vascularity, flow velocity and distribution, complexity of vascular structures [fractal dimension], regularity of vascular flow and vessel pulsatility) assessed using the high-resolution CEUS test and compared with the results of standard imaging prior to NACT, between cycles 2 & 3 of NACT and upon completion of NACT 2. Immunohistochemical markers of angiogenesis, proliferation and vascular mimicry measured using standard immunohistochemistry techniques prior to NACT, between cycles 2 & 3 of NACT and upon completion of NACT

—

Secondary

Measure	Time frame
1. Phenotypes of all cases determined using immunohistochemistry and subtype analysis prior to NACT 2. Germline mutations and somatic BRCA1/2 gene mutations assessed using panel sequencing prior to NACT	—

Countries

England, United Kingdom

Contacts

Public ContactJaideep Singh Rait

j.rait@nhs.net+44 (0)1622 729000

Outcome results

None listed

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