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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
Sponsor:
Information provided by (Responsible Party):
St. Olavs Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Breast Neoplasms Drug: SonoVue Procedure: Focused Ultrasound Phase 1 Phase 2

Study Design
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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

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Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Occurrence of adverse effects [ Time Frame: 8 weeks ]
    questionnaire 'Common toxicity criteria'


Eligibility 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
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Margrete Haram, md +47 47416976 margrete.haram@stolav.no
Contact: Eva Hofsli, PhD, MD

Locations
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Norway
St.Olavs Hospital Recruiting
Trondheim, Norway
Contact: Margrete Haram, MD    +47 47416976    margrete.haram@stolav.no   
Sponsors and Collaborators
St. Olavs Hospital
Investigators
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Study Director: Arne Solberg, PhD, MD St. Olavs Hospital
More Information
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by St. Olavs Hospital:
Contrast Agent BR
SonoVue
Ultrasonic Therapy
 Neoplasm Metastasis
Liver
Microbubbles
Additional relevant MeSH terms:
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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