Ignite Creation Date:
2024-05-06 @ 11:15 AM
Last Modification Date:
2024-10-26 @ 12:42 PM
Study NCT ID:
NCT03477019
Status:
COMPLETED
Last Update Posted:
2023-01-19
First Post:
2018-03-19
Brief Title:
Ultrasound-enhanced Delivery of Chemotherapy to Patients With Liver Metastasis From Breast- and Colorectal Cancer
Sponsor:
St Olavs Hospital
Organization:
St Olavs Hospital
Study Overview
Official Title:
Ultrasound-enhanced Delivery of Chemotherapy to Patients With Liver Metastasis From Breast- and Colorectal Carcinoma- a Randomized Trial
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2018-002814-11 | EUDRACT_NUMBER | None | None |