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

  • STATUS
    Recruiting
  • End date
    Sep 23, 2023
  • participants needed
    30
  • sponsor
    St. Olavs Hospital
Updated on 23 March 2022

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.

Details
Condition Carcinoma, Pancreatic Ductal
Treatment Chemotherapy, SonoVue
Clinical Study IdentifierNCT04146441
SponsorSt. Olavs Hospital
Last Modified on23 March 2022

Eligibility

Yes No Not Sure

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
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