Clinical trial NCT02407613: Efficacy of MR-HIFU Ablation of Breast Cancer
Official title: Efficacy of Magnetic Resonance-guided High Intensity Focused Ultrasound for the Ablation of Breast Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Breast Cancer
Keywords: breast cancer
MR-HIFU
ablation
non-invasive treatment
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
First posted: 2015-04-03
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study evaluates the efficacy of MR-HIFU ablation of breast cancer. Ten patients with early-stage breast cancer with a maximum diameter of 3 cm will undergo MR-HIFU ablation, followed by MRI and surgical resection to evaluate treatment effect. The main purpose of the study is to demonstrate the feasibility of total tumor ablation with MR-HIFU. The secondary objective is safety assessment.


Eligibility criteria: Inclusion Criteria:

* Women, aged 18 years and older.
* Able to give informed consent herself.
* World Health Organization (WHO) performance score ≤ 2.
* Biopsy proven cT1-2 N0-2 MX invasive breast cancer with a size of ≤ 3.0 cm.
* Histological type of tumor: invasive ductal carcinoma (IDC), not otherwise specified (NOS) or no special type (NST).
* The target breast fits in the cup of the dedicated MR-HIFU breast system.
* Patient weight is limited to ≤ 90 kg, because of restrictions to the HIFU table top.

Additional inclusion criteria based on DCE-MRI findings:

* The distance of the tumor, including a 5 mm margin around the tumor, from the skin, nipple and pectoral wall is at least 1.0 cm measured on MRI.
* The tumor is located within the reach of the HIFU beam produced by the transducers in the HIFU breast system.

Exclusion Criteria:

* Prior treatment with: neo-adjuvant systemic therapy in the past 3 months or radiotherapy or thermal therapy or surgery of any kind in the targeted breast.
* Contraindications to MR imaging according to the hospital guidelines (e.g. pacemaker in situ, severe claustrophobia, big metal implants, body size incompatible with MR bore).
* Contraindications to administration of gadolinium-based contrast agent, including: prior allergic reaction to a gadolinium-based contrast agent, kidney disease (e.g. nephrogenic systemic fibrosis, nephrogenic fibrosing dermopathy) and/or renal failure (GFR \< 30 ml/min/1,73m2).
* Contra-indications for procedural sedation analgesia with Propofol and Esketamine or Propofol and Remifentanil.
* Extensive intraductal components in the lesion determined by biopsy.
* Scar tissue or surgical clips in the HIFU beam path.
* Inability to lie in prone position.
* Pregnancy or lactation.
* Communication barrier with patient.

The following groups of patients will be excluded because the risk of adjuvant over- or undertreatment due to performing the Bloom and Richardson (B\&R) grading on the tumor biopsy is considered to high:

* N0, Her2neu negative, \<35 years, ≤1cm (T1a/b) with B\&R grade 1 or 2 on biopsy.
* N0 Her2neu negative, ER/PR negative (triple negative), 35-70yr, 1.1-2cm (T1c) with B\&R grade 1 or 2 on biopsy.
* N0, Her2neu negative, ER/PR positive \> 50%, ductal carcinoma, 60-70yr, 1.1-2cm (T1c), with B\&R grade 3 on biopsy and if the MammaPrint is not reimbursed by health insurance also for grade 1 on biopsy.
* N0, Her2neu negative, ER/PR positive, ductal carcinoma, 35-60yr, 1.1-2cm (T1c) with B\&R grade 1 on biopsy.
* N0, Her2neu negative, ER/PR positive, but ≤50%, ductal carcinoma, 60-70yr, 1.1-2cm (T1c) with B\&R grade 1.

The following group of patients will be excluded based on the results of the MammaPrint:

• Only if the MammaPrint is reimbursed by health insurance: N0, Her2neu negative, ER/PR positive, \> 50% ductal carcinoma, 60-70yr, 1.1-2cm (T1c), with B\&R grade 1 and MammaPrint high risk.

Primary outcomes:
measure: Amount of ablated tissue at histopathological examination
timeFrame: 2-3 weeks (after surgery is performed)
measure: Presence of non-perfused volumes on DCE-MRI
timeFrame: 1 week after MR-HIFU ablation
Secondary outcomes:
measure: Number of patients with adverse events
timeFrame: Approximately 2 to 3 weeks
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
Study officials:
affiliation: UMC Utrecht
name: Manon NG Braat, MD
role: PRINCIPAL_INVESTIGATOR
References: