Ultrasound-enhanced Delivery of Chemotherapy to Patients With Liver Metastasis From Breast- and Colorectal Cancer
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ClinicalTrials.gov Identifier: NCT03477019 |
Recruitment Status :
Recruiting
First Posted : March 26, 2018
Last Update Posted : February 8, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Colorectal Neoplasms Breast Neoplasms | Drug: SonoVue Procedure: Focused Ultrasound | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | 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. |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Ultrasound-enhanced Delivery of Chemotherapy to Patients With Liver Metastasis From Breast- and Colorectal Carcinoma- a Randomized Trial |
Actual Study Start Date : | November 12, 2018 |
Estimated Primary Completion Date : | December 2021 |
Estimated Study Completion Date : | December 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Breast cancer target lesion
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
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. |
Breast cancer control lesion
This arm will only receive treatment with conventional chemotherapy for breastcancer 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. |
Experimental: Colorectal cancer target lesion
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
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. |
Colorectal cancer control lesion
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. |
- difference in measured response between treated and untreated lesions [ Time Frame: From baseline examination CT to response evaluation CT: 10-12 weeks ]Response is measured in change in size of the treated metastases.
- Occurrence of adverse effects [ Time Frame: 8 weeks ]questionnaire 'Common toxicity criteria'

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Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03477019
Contact: Margrete Haram, md | +47 47416976 | margrete.haram@stolav.no | |
Contact: Eva Hofsli, PhD, MD |
Norway | |
St.Olavs Hospital | Recruiting |
Trondheim, Norway | |
Contact: Margrete Haram, MD +47 47416976 margrete.haram@stolav.no |
Study Director: | Arne Solberg, PhD, MD | St. Olavs Hospital |
Responsible Party: | St. Olavs Hospital |
ClinicalTrials.gov Identifier: | NCT03477019 |
Other Study ID Numbers: |
2018/13 2018-002814-11 ( EudraCT Number ) |
First Posted: | March 26, 2018 Key Record Dates |
Last Update Posted: | February 8, 2021 |
Last Verified: | February 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Contrast Agent BR SonoVue Ultrasonic Therapy |
Neoplasm Metastasis Liver Microbubbles |
Neoplasms Neoplasm Metastasis Breast Neoplasms Colorectal Neoplasms Neoplastic Processes Pathologic Processes Neoplasms by Site Breast Diseases Skin Diseases |
Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |