In patients with breast cancer, can imaging specialists be taught to use an advanced ultrasound technique to successfully find cancer deposits in armpit sentinel lymph nodes with microbubbles injected into the breast?

Multicentre phase II trial to assess technical feasibility and diagnostic accuracy of intradermal microbubbles and contrast-enhanced ultrasound to identify sentinel lymph node metastases in breast cancer patients compared to axillary surgery following training and mentorship of imaging specialists

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN10259902

Enrollment

250

Registered

2020-04-30

Start date

2020-10-05

Completion date

Unknown

Last updated

2021-01-05

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 breast

Interventions

Patient Intervention: 1. Following written informed consent and registration, a contrast-enhanced ultrasound and biopsy of axillary sentinel lymph nodes (with clip marking) will be und

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Newly diagnosed early invasive carcinoma of the breast with a normal B-mode axillary ultrasound or benign biopsy of indeterminate lymph nodes 2. Surgery as first planned treatment 3. Participant is willing and able to give informed consent for participation in the trial 4. Female, aged 18 years or above 5. In the Investigator’s opinion, adhering to the trial recommendations and governance

Exclusion criteria

Exclusion criteria: 1. Previous ipsilateral axillary surgery or ipsilateral breast cancer surgery/ radiotherapy 2. Female participant who is pregnant, lactating or planning pregnancy during the course of the trial 3. Contraindication to contrast 4. Patient cannot provide consent 5. Inflammatory or locally advanced breast cancer 6. Metastatic breast cancer 7. Inability to raise ipsilateral arm above head 8. Multiple medical co-morbidities (ASA 4 or above)

Design outcomes

Primary

Measure	Time frame
1. Technical feasibility will be assessed by 75% of imaging specialists achieving; >85% visualization of tumour draining axillary SLN, >80% successful core biopsy (LN tissue retrieved) rate and >80% concordance with SLN identified surgically with SLNE. 2. Diagnostic performance will be assessed by calculating the overall pooled sensitivity, specificity, positive predictive value, negative predictive value of CEUS SLN core biopsy as a test to identify SLN metastases as compared to axillary surgery and the prevalence of LN metastases. An overall sensitivity >50% will be considered acceptable.	—

Measure

Time frame

1. Technical feasibility will be assessed by 75% of imaging specialists achieving; >85% visualization of tumour draining axillary SLN, >80% successful core biopsy (LN tissue retrieved) rate and >80% concordance with SLN identified surgically with SLNE. 2. Diagnostic performance will be assessed by calculating the overall pooled sensitivity, specificity, positive predictive value, negative predictive value of CEUS SLN core biopsy as a test to identify SLN metastases as compared to axillary surgery and the prevalence of LN metastases. An overall sensitivity >50% will be considered acceptable.

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Secondary

Measure	Time frame
Measured using case report forms completed at the time of procedure: 1. Time taken to perform each CEUS SLN core biopsy procedure 2. Total volume of axillary disease at the end of primary surgical treatment for each patient 3. Bleeding complications (CEUS SLN core biopsy and subsequent axillary surgery) 4. Infective complications (CEUS SLN core biopsy and subsequent axillary surgery) 5. Pain/ sensory disturbance (CEUS SLN core biopsy and subsequent axillary surgery) 6. Patient satisfaction (CEUS SLN core biopsy and subsequent axillary surgery) 7. Prospective audit of each unit’s detection rate of LN metastases with grey-scale axillary ultrasound	—

Measure

Time frame

Measured using case report forms completed at the time of procedure: 1. Time taken to perform each CEUS SLN core biopsy procedure 2. Total volume of axillary disease at the end of primary surgical treatment for each patient 3. Bleeding complications (CEUS SLN core biopsy and subsequent axillary surgery) 4. Infective complications (CEUS SLN core biopsy and subsequent axillary surgery) 5. Pain/ sensory disturbance (CEUS SLN core biopsy and subsequent axillary surgery) 6. Patient satisfaction (CEUS SLN core biopsy and subsequent axillary surgery) 7. Prospective audit of each unit’s detection rate of LN metastases with grey-scale axillary ultrasound

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Countries

United Kingdom

Contacts

Public ContactKarina Cox

karina.cox@nhs.net+44 (0)1622 224111

Outcome results

None listed

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