A Phase 1/2 interventional study of SonoVue and Focused Ultrasound in Colorectal Neoplasms and Breast Neoplasms, sponsored by St. Olavs Hospital. Completed at 1 site in Norway. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-01-19.
Sponsored by St. Olavs Hospital · Phase 1/2, Interventional, and Treatment
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.
Exclusion Criteria:
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.
Drug: SonoVue · Procedure: Focused Ultrasound
This arm will only receive treatment with conventional chemotherapy for breastcancer and microbubbles intravenously.
Drug: 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.
Drug: SonoVue · Procedure: Focused Ultrasound
This arm will only receive treatment with conventional chemotherapy for colorectal cancer and microbubbles intravenously.
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.
ultrasound pulses will be generated by a clinically approved ultrasound skanner and probe.
difference in measured response between treated and untreated lesions
Response is measured in change in size of the treated metastases.
Time frame: From baseline examination CT to response evaluation CT: 10-12 weeks
Occurrence of adverse effects
questionnaire 'Common toxicity criteria'
Time frame: 8 weeks
Plan to share: Undecided — Yes.Individual participant data that underlie the results reported in this article, after deidentification(text, tables, figures, and appendices). Protocol can be shared beginning 3 months and ending 5 years following article publication. Interested researchers who provide a reasonable, sound proposal are encouraged to direct this to the first author.
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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St. Olavs Hospital