Evaluation of Sonalleve MR-HIFU for Ablation of Locally Advanced Non-resectable and Metastatic Pancreatic Cancer in Patients with Non-progressive Disease under First-line Chemotherapy: Feasibility and Safety Clinical Study [HIFU-PANC]

Phase 1

Recruiting

Conditions: C25
Malignant neoplasm of pancreas

Registration Number: DRKS00033237

Lead Sponsor: niversität zu Köln

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 25

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

- Treatment target zone < 10mm from the skin.
- Body weight > 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.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Technical feasibility with the objective defined as non-perfused volume after thermal ablation in relation to target volume.

Secondary Outcome Measures

Name	Time	Method
safety; Pain reduction (BPI); Pain medication (change in frequency, type and dosage); Performance status (ECOG); Impact on QoL; Impact on PFS, Overall survival