Back to resultsUltrasound-enhanced Delivery of Chemotherapy to Patients With Liver Metastasis From Breast- and Colorectal Cancer
Primary Purpose
Colorectal Neoplasms, Breast Neoplasms
Status
Completed
Phase
Phase 1
Locations
Norway
Study Type
Interventional
Intervention
SonoVue
Focused Ultrasound
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Neoplasms focused on measuring Contrast Agent BR, SonoVue, Ultrasonic Therapy, Neoplasm Metastasis, Liver, Microbubbles
Eligibility 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
Sites / Locations
- St.Olavs Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Other
Experimental
Other
Arm Label
Breast cancer target lesion
Breast cancer control lesion
Colorectal cancer target lesion
Colorectal cancer control lesion
Arm Description
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.
This arm will only receive treatment with conventional chemotherapy for breastcancer and microbubbles intravenously.
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.
This arm will only receive treatment with conventional chemotherapy for colorectal cancer and microbubbles intravenously.
Outcomes
Primary Outcome Measures
difference in measured response between treated and untreated lesions
Response is measured in change in size of the treated metastases.
Secondary Outcome Measures
Occurrence of adverse effects
questionnaire 'Common toxicity criteria'
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03477019
Brief Title
Ultrasound-enhanced Delivery of Chemotherapy to Patients With Liver Metastasis From Breast- and Colorectal Cancer
Official Title
Ultrasound-enhanced Delivery of Chemotherapy to Patients With Liver Metastasis From Breast- and Colorectal Carcinoma- a Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
November 12, 2018 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Olavs Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms, Breast Neoplasms
Keywords
Contrast Agent BR, SonoVue, Ultrasonic Therapy, Neoplasm Metastasis, Liver, Microbubbles
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Breast cancer target lesion
Arm Type
Experimental
Arm Description
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.
Arm Title
Breast cancer control lesion
Arm Type
Other
Arm Description
This arm will only receive treatment with conventional chemotherapy for breastcancer and microbubbles intravenously.
Arm Title
Colorectal cancer target lesion
Arm Type
Experimental
Arm Description
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.
Arm Title
Colorectal cancer control lesion
Arm Type
Other
Arm Description
This arm will only receive treatment with conventional chemotherapy for colorectal cancer and microbubbles intravenously.
Intervention Type
Drug
Intervention Name(s)
SonoVue
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Focused Ultrasound
Intervention Description
ultrasound pulses will be generated by a clinically approved ultrasound skanner and probe.
Primary Outcome Measure Information:
Title
difference in measured response between treated and untreated lesions
Description
Response is measured in change in size of the treated metastases.
Time Frame
From baseline examination CT to response evaluation CT: 10-12 weeks
Secondary Outcome Measure Information:
Title
Occurrence of adverse effects
Description
questionnaire 'Common toxicity criteria'
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arne Solberg, PhD, MD
Organizational Affiliation
St. Olavs Hospital
Official's Role
Study Director
Facility Information:
Facility Name
St.Olavs Hospital
City
Trondheim
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
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.
Learn more about this trial
Ultrasound-enhanced Delivery of Chemotherapy to Patients With Liver Metastasis From Breast- and Colorectal Cancer
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