Ignite Creation Date:
2024-05-06 @ 1:52 PM
Last Modification Date:
2024-10-26 @ 1:21 PM
Study NCT ID:
NCT04146441
Status:
COMPLETED
Last Update Posted:
2023-01-19
First Post:
2019-10-29
Brief Title:
Ultrasound-enhanced Uptake of Chemotherapy in Patients With Inoperable Pancreatic Ductal Adenocarcinoma
Sponsor:
St Olavs Hospital
Organization:
St Olavs Hospital
Study Overview
Official Title:
Ultrasound-enhanced Uptake of Chemotherapy in Patients With Inoperable Pancreatic Ductal Adenocarcinoma - A Randomized Controlled 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:
PDAC
Brief Summary:
Patients with inoperable pancreatic cancer have extremely poor prognosis with five year survival below 8 in Norway Life-prolonging chemotherapy has very limited effect but is the only therapeutic option for these patients This tumor is characterized by poor uptake and chemoresistance Toxic effects on healthy tissue restrict doses applied and maintenance of treatment intensity This severely limits clinical outcome Increasing the local uptake of chemotherapy has potential benefits for patients in connection to side effects survival and possible cure Treatment with Focused Ultrasound FUS combined with microbubbles MBs is proved promising to improve treatment response in animal and clinical trials Ultrasound can induce biological effects deep inside the body without surgical intervention This opens for local delivery of drugs at desired sites FUS in combination with regular contrast MBs has been reported to influence the delivery of drugs to tumors
In this trial FUS and MB will be applied to locally advanced pancreatic cancers shortly after the administration of conventional chemotherapy Primary aim of the trial is to investigate whether the effect of the cytostatic drug measured in tumor volume can be increased
In this trial FUS and MB will be applied to locally advanced pancreatic cancers shortly after the administration of conventional chemotherapy Primary aim of the trial is to investigate whether the effect of the cytostatic drug measured in tumor volume can be increased
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 |
|---|---|---|---|
| 2019-001736-57 | EUDRACT_NUMBER | None | None |