MedPath

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

Phase 2
Completed
Conditions
Carcinoma, Pancreatic Ductal
Interventions
Combination Product: SonoVue
Drug: Chemotherapy
Registration Number
NCT04146441
Lead Sponsor
St. Olavs Hospital
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 available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
20
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
SonoVueChemotherapySonoVue + chemotherapy
controlChemotherapychemotherapy
SonoVueSonoVueSonoVue + chemotherapy
Primary Outcome Measures
NameTimeMethod
Volume change of primary tumor8 weeks

measured by segmented tumor volumes on Computed Tomography of primary PDAC tumor from before treatment (baseline) to after 1 cycle of treatment

Secondary Outcome Measures
NameTimeMethod
Rate of reported toxicity8 weeks

Toxicity reported by patients during structured interview after treatment. Type of side effects and severity according to Common Toxicity Criteria (CTC)

Number of down-staged tumors from stage III to stage II1 year

Trial Locations

Locations (1)

Department of Radiology, St Olavs Hospital

🇳🇴

Trondheim, Norway

Department of Radiology, St Olavs Hospital
🇳🇴Trondheim, Norway

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.