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

Phase 1

Completed

• Conditions: Colorectal Neoplasms; Breast Neoplasms
• Interventions: Drug: SonoVue; Procedure: Focused Ultrasound

• Registration Number: NCT03477019
• Lead Sponsor: St. Olavs Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-19
• Study First Submitted QC: 2018-03-19
• Study First Posted: 2018-03-26
• Study Start: 2018-11-12
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-17
• Last Update Posted: 2023-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Breast cancer target lesion	SonoVue	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.
Colorectal cancer control lesion	SonoVue	This arm will only receive treatment with conventional chemotherapy for colorectal cancer and microbubbles intravenously.
Breast cancer target lesion	Focused Ultrasound	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.
Breast cancer control lesion	SonoVue	This arm will only receive treatment with conventional chemotherapy for breastcancer and microbubbles intravenously.
Colorectal cancer target lesion	SonoVue	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.
Colorectal cancer target lesion	Focused Ultrasound	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Occurrence of adverse effects	8 weeks	questionnaire 'Common toxicity criteria'

Trial Locations

Locations (1)

St.Olavs Hospital; 🇳🇴 Trondheim, Norway