Ultrasound-enhanced Delivery of Chemotherapy to Patients With Liver Metastasis From Breast- and Colorectal Cancer

St. Olavs Hospital

Status and phase: Completed; Phase 2; Phase 1

Conditions: Breast Neoplasms; Colorectal Neoplasms

Treatments: Drug: SonoVue; Procedure: Focused Ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT03477019

2018-002814-11 (EudraCT Number)

2018/13

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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17 participants in 4 patient groups

Breast cancer target lesion

Experimental group

Description:

This arm will receive experimental treatment of focused ultrasound. In addition this arm will receive treatment with microbubbles intravenously and conventional chemotherapy for breast cancer.

Treatment:

Drug: SonoVue

Procedure: Focused Ultrasound

Breast cancer control lesion

Other group

Description:

This arm will only receive treatment with conventional chemotherapy for breastcancer and microbubbles intravenously.

Treatment:

Drug: SonoVue

Colorectal cancer target lesion

Experimental group

Description:

This arm will receive experimental treatment of focused ultrasound. In addition this arm will receive treatment with microbubbles intravenously and conventional chemotherapy for colorectal cancer.

Treatment:

Drug: SonoVue

Procedure: Focused Ultrasound

Colorectal cancer control lesion

Other group

Description:

This arm will only receive treatment with conventional chemotherapy for colorectal cancer and microbubbles intravenously.

Treatment:

Drug: SonoVue