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

Breast Neoplasms Clinical Trial

Official title:

Ultrasound-enhanced Delivery of Chemotherapy to Patients With Liver Metastasis From Breast- and Colorectal Carcinoma- a Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03477019
• Other study ID #: 2018/13
• Secondary ID: 2018-002814-11
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: November 12, 2018
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2023
• Source: St. Olavs Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Colorectal Neoplasms
• Neoplasm Metastasis
• Neoplasms

Intervention

Drug:
• SonoVue
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.

Procedure:
• Focused Ultrasound
ultrasound pulses will be generated by a clinically approved ultrasound skanner and probe.

Locations

Country	Name	City	State
Norway	St.Olavs Hospital	Trondheim

Sponsors (1)

Lead Sponsor	Collaborator
St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	difference in measured response between treated and untreated lesions	Response is measured in change in size of the treated metastases.	From baseline examination CT to response evaluation CT: 10-12 weeks
Secondary	Occurrence of adverse effects	questionnaire 'Common toxicity criteria'	8 weeks