Clinical trial NCT03477019: Ultrasound-enhanced Delivery of Chemotherapy to Patients With Liver Metastasis From Breast- and Colorectal Cancer
Official title: Ultrasound-enhanced Delivery of Chemotherapy to Patients With Liver Metastasis From Breast- and Colorectal Carcinoma- a Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Colorectal Neoplasms
Breast Neoplasms
Keywords: Contrast Agent BR
SonoVue
Ultrasonic Therapy
Neoplasm Metastasis
Liver
Microbubbles
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
First posted: 2018-03-26
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: difference in measured response between treated and untreated lesions
timeFrame: From baseline examination CT to response evaluation CT: 10-12 weeks
Secondary outcomes:
measure: Occurrence of adverse effects
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St.Olavs Hospital
Study officials:
affiliation: St. Olavs Hospital
name: Arne Solberg, PhD, MD
role: STUDY_DIRECTOR
References: