Ultrasound-enhanced Uptake of Chemotherapy in Patients Wi... | NCT04146441

Studies
Ultrasound-enhanced Uptake of Chemotherapy in Patients With Inoperable Pancreatic Ductal Adenocarcinoma

NCT04146441

Sponsor

St. Olavs Hospital

Status

Completed

Last Update Posted

Jan 19, 2023Actual

Enrollment

20Actual

Phase

Phase 2

Conditions

Carcinoma, Pancreatic Ductal

Interventions

SonoVue
Chemotherapy

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2019-001736-57	EudraCT Number

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 10, 2020Actual

Primary Completion Date

Dec 31, 2022Actual

Completion Date

Dec 31, 2022Actual

First Submitted Date

Oct 29, 2019

First Submission Date that Met QC Criteria

Oct 29, 2019

First Posted Date

Oct 31, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 17, 2023

Last Update Posted Date

Jan 19, 2023Actual

Name	Class
Norwegian University of Science and Technology	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SonoVue	Experimental	SonoVue + chemotherapy	Combination Product: SonoVue Drug: Chemotherapy
control	Active Comparator	chemotherapy	Drug: Chemotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SonoVue	Combination Product	1,0 ml SonoVue 8ul/ml dispersion is given 9 times at 3,5 minute intervals 9 times, a total dosage of 9 ml. The experimental treatment lasts for 31,5 minutes every treatment day. Administered by authorized site personnel only

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Volume change of primary tumor	measured by segmented tumor volumes on Computed Tomography of primary PDAC tumor from before treatment (baseline) to after 1 cycle of treatment	8 weeks

Secondary Outcomes

Measure	Description	Time Frame
Number of down-staged tumors from stage III to stage II		8 weeks
Number of down-staged tumors from stage III to stage II		1 year
Rate of reported toxicity

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Radiologically verified stage III or IV PDAC or medically inoperable stage IIB T3 PDAC
eligible for 1st line treatment with FOLFIRINOX, Gemcitabine -nab Paclitaxel, or Gemcitabine monotherapy.
ECOG 0 - 1

Exclusion Criteria:

Known contraindications for SonoVue
Hematological bleeding status before experimental treatment:
Hb < 8g/dL, trc < 80 x10 superscr 9/l, APTT˃ 45s, INR ˃ 1,5
Pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

89 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eva Hofsli, md phd	St. Olavs Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Radiology, St Olavs Hospital		Trondheim			Norway

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Individual participant data that underlie the results reported in this article, after deidentification(text, tables, figures, and appendices). Interested researchers who provide a reasonable, sound proposal are encouraged to direct this to the first author.

Types

Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)

Time Frame

Protocol can be shared beginning 3 months and ending 5 years following article publication.

Access Criteria

Researchers who provide a reasonable, sound proposals are encouraged to direct this to the first author at margrete.haram@stolav.no

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D021441	Carcinoma, Pancreatic Ductal

Ancestor Terms

ID	Term
D044584	Carcinoma, Ductal
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C420843	contrast agent BR1
D004358	Drug Therapy

Ancestor Terms

ID	Term
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided