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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-002814-11 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breast cancer target lesion | Experimental | 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. |
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| Breast cancer control lesion | Other | This arm will only receive treatment with conventional chemotherapy for breastcancer and microbubbles intravenously. |
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| Colorectal cancer target lesion | Experimental | 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. |
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| Colorectal cancer control lesion | Other | This arm will only receive treatment with conventional chemotherapy for colorectal cancer and microbubbles intravenously. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SonoVue | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of adverse effects | questionnaire 'Common toxicity criteria' | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arne Solberg, PhD, MD | St. Olavs Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St.Olavs Hospital | Trondheim | Norway |
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.
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D001943 | Breast Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C420843 | contrast agent BR1 |
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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.
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| Focused Ultrasound | Procedure | ultrasound pulses will be generated by a clinically approved ultrasound skanner and probe. |
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |