Status:
COMPLETED
Ultrasound-enhanced Delivery of Chemotherapy to Patients With Liver Metastasis From Breast- and Colorectal Cancer
Lead Sponsor:
St. Olavs Hospital
Conditions:
Colorectal Neoplasms
Breast Neoplasms
Eligibility:
All Genders
18-90 years
Phase:
PHASE1
PHASE2
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 can...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT03477019
Start Date
November 12 2018
End Date
December 31 2022
Last Update
January 19 2023
Active Locations (1)
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1
St.Olavs Hospital
Trondheim, Norway