Colorectal Neoplasms, Breast Neoplasms
Conditions
Keywords
Contrast Agent BR, SonoVue, Ultrasonic Therapy, Neoplasm Metastasis, Liver, Microbubbles
Brief summary
The aim of this clinical trial is to investigate whether the therapeutic response of chemotherapy can be improved by focused ultrasound and microbubbles. Patients with liver metastases from breast cancer and colorectal cancer will be included. Computer Tomography (CT) will be performed as a baseline scan before treatment start. Two metastases in each patients liver will be preselected and randomized to either target lesion to be treated or control lesion to serve as internal control. The patients will receive conventional treatment with chemotherapy according to national guidelines. After intravenous chemotherapy infusion the patients will receive the experimental treatment. The target lesion will get focused ultrasound (FUS). Simultaneously repeated bolus-doses of microbubbles will be administered intravenously. The investigators will measure the difference in response between FUS- treated and -untreated lesions on the post-treatment CT scan.
Interventions
DRUGSonoVue
consists of microbubbles containing sulfur hexafluoride stabilized by phospholipids. Bolus doses à 1,0ml administered every 3.5 minutes , repeated 9 times. Total duration of treatment: 31,5 minutes. This treatment will be repeated maximally 4 times at 2 or 3 week intervals, depending on the patient's diagonse and treatment protocol.
PROCEDUREFocused Ultrasound
ultrasound pulses will be generated by a clinically approved ultrasound skanner and probe.
Sponsors
St. Olavs Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Two liver metastases in every patient are preselected on baseline computer tomography. These will be randomized to either 1) target lesion to be treated or 2) control lesion. Difference in response (pre- and post-treatment measure) between treated lesions and control lesions will be the primary outcome of the trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Histologically verified breast carcinoma or colorectal carcinoma * 2 or multiple liver metastases * considered eligible by a consulting oncologist for first line treatment with chemotherapy in the group of taxanes (patients with breast cancer) or the combination regimen FOLFIRI (patients with colorectal carcinoma) * Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to ICH GCP, and national/local regulations
Exclusion criteria
* Known contraindications for ultrasound contrast-enhancement agent Sonovue® (Bracco) * Hematological bleeding status before experimental treatment: Hb \< 8g/dL, trc \< 80 x109/l, APTT˃ 45s, INR ˃ 1,5 * Considered eligible for surgical removal of liver metastases * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| difference in measured response between treated and untreated lesions | From baseline examination CT to response evaluation CT: 10-12 weeks | Response is measured in change in size of the treated metastases. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of adverse effects | 8 weeks | questionnaire 'Common toxicity criteria' |
Countries
Norway
Outcome results
None listed