C25
Conditions
Interventions
Group 1: This is a single arm study. After 1st cycle of Chemotherapy with FOLFORINOX, Chemotherapy will be paused for max. 29 days. Patients receive a singe treatement with HIFU, followed for 28 days
Sponsors
Universität zu Köln
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Histological or cytological confirmed unresectable ductal adenocarcinoma of the pancreas (PDAC) (AJCC stage IIIb, IV) with no prior surgical resection. - Patients need to receive standard of care (SOC) chemotherapy and must not show any signs of progression after 3 months of chemotherapy (at least stable disease). - Patients must be eligible for MR imaging and MR-HIFU sessions. - PDAC identifiable, targetable, and reachable in MRI for treatment. Patients need to be eligible for SOC chemotherapy with adequate renal, hepatic and bone marrow function
Exclusion criteria
Exclusion criteria: - Treatment target zone 140 kg - Any MR-unsafe implant or pacemaker. Any MR-conditional implant that requires scanning with less than 3 Tesla or adjustments to the scan protocol - Patients with contraindication to Buscopan (Hyoscine). - Major surgical interventions within 4 weeks before study enrolment . Wound healing must be also completed before first application of study treatment. - Medical history of interstitial lung disease (ILD) or pulmonary fibrosis. - Hypersensitivity against any chemotherapeutic drugs administered as SOC - Active or uncontrolled bacterial, viral, or fungal infection that requires systemic treatment. - Abnormal coagulation and current anticoagulant therapy. - Any other disease and condition that would contraindicate MR-HIFU treatments and MR scans such as metal stents or other metal implants in the vicinity of treatment site, pacemakers, claustrophobia etc. and known allergies to contrast agents. - Scars that cannot be protected or wound clips, implants, or prostheses in the planned path of the ultrasound beam.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Technical feasibility with the objective defined as non-perfused volume after thermal ablation in relation to target volume. | — |
Secondary
| Measure | Time frame |
|---|---|
| safety; Pain reduction (BPI); Pain medication (change in frequency, type and dosage); Performance status (ECOG); Impact on QoL; Impact on PFS, Overall survival | — |
Countries
Germany
Contacts
Public ContactDirk Waldschmidt
Universitätsklinikum Köln
Outcome results
None listed