Percutaneous Holmium Injection in Pancreatic Cancer

Trial Title: Percutaneous Holmium Injection in Pancreatic Cancer

NCT ID: NCT05880472

Condition: Pancreas Cancer

Conditions: Official terms:
Pancreatic Neoplasms

Conditions: Keywords:
Intratumoral therapy
Brachytherapy
Holmium-166
Holmium-166 microspheres

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Device
Intervention name: Intratumoral
Description: Comparable to CE-marked QuiremSpheres(R) outside of intended use with minor altered specification.
Arm group label: Intervention arm

Other name: Intratumoural holmium-166 microspheres

Summary: This investigator initiated study with a medical device aims to assess the safety and feasibility of percutaneous injected holmium-166 microsphere brachytherapy in patients with irresectable pancreatic cancer.

Detailed description: Objective: To test the feasibility and safety of minimally invasive CT-guided percutaneous holmium-166 microsphere brachytherapy in patients suffering from irresectable pancreatic cancer. Study design: This is a single centre, prospective, safety and feasibility study with a medical device in a maximum of 6 patients. Study population: Patients diagnosed with pathologically proven pancreatic adenocarcinoma, who are ineligible for exploratory surgery or surgical resection of the tumour after 8 cycles of systemic therapy or less in case of unacceptable toxicity, patient refusal or patients who are ineligible for systematic therapy. Intervention (if applicable): A radioactive medical device will be implanted by CT-guided percutaneous injection. The medical device in question are beta-minus (β-) and gamma(γ) emitting holmium-166 poly(L-lactic acid) microspheres (166Ho-PLLA-MS, HoMS) in a 0.1% Pluronic or cellulose based suspension. Main study parameters/endpoints: The main endpoint is to establish the feasibility and safety of CT-guided percutaneous intratumoural implantation of HoMS in irresectable pancreatic adenocarcinoma. Feasibility is established by evaluating the average tumour absorbed dose in Gray (Gy) calculated on SPECT and comparing to the pre-operative planning. Intratumoural microsphere distribution, absorbed tumour dose and non-target absorbed tumour dose are analysed using MRI and CT quantification. Safety is evaluated using the Common Terminology Criteria for Adverse Events (CTCAE v5.0), events deemed 'unlikely', 'probably' or 'definitely' related to the implantation procedure or implanted medical device. As exploratory endpoints, tumour response (RECIST1.1), pain (NRS) and Quality of Life is evaluated. Total follow-up is 16 weeks.

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. Female or male aged 18 years and over. 2. Pathologically proven pancreatic adenocarcinoma, also known as pancreatic ductal adenocarcinoma. 3. Patient is deemed ineligible for surgical resection of the pancreatic cancer: 1. in accordance with consensus at the multidisciplinary meetings/discussions, 2. and/or the patient refuses to undergo surgical resection out of personal choice 4. Life expectancy of 16 weeks or longer. 5. World Health Organisation (WHO) Performance status 0-1 6. One or more measurable pancreatic tumours of at least 20 mm in the longest diameter by spiral CT or MRI according to the Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 criteria. 7. Negative pregnancy test for women of childbearing potential. Exclusion Criteria: 1. Radiation therapy within the last 4 weeks before the start of study therapy. 2. Chemotherapy within the last 2 weeks before the start of study therapy. 3. Calcifications in the pancreas or tumour that are highly expected to obstruct the needle tract 4. Any unresolved toxicity ≥ grade 3 from the National Cancer Institute (NCI), Common Terminology Criteria for Adverse Events (CTCAE version 5.0) from previous anti-cancer therapy. 5. Leukocytes < 3.0 10^9/l and/or platelet count < 75 10^9/l. 6. Kidney failure: Creatine > 165 µmol/l and/or eGFR < 60 ml/min/1,73m^2 7. Significant cardiac event (e.g. myocardial infarction, superior vena cava (SVC) syndrome, New York Heart Association (NYHA) classification of heart disease ≥2 within 3 months before entry, or presence of cardiac disease that in the opinion of the Investigator increases the risk of ventricular arrhythmia. 8. Patient is deemed ineligible for implantation of 166Ho by an expert panel (surgeon, nuclear medicine physician, interventional radiologist, radiologist, and researcher) due to tumour anatomy, nearby structures, patient status or a combination. 9. Pregnancy or breast feeding (women of child-bearing potential). 10. Patients suffering from psychic disorders that make a comprehensive judgement impossible, such as psychosis, hallucinations and/or depression. 11. Patients who are declared incompetent.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Radboud University Medical Centre

Address:
City: Nijmegen
Zip: 6525GA
Country: Netherlands

Status: Recruiting

Contact:
Last name: Ysbrand Willink, MSc

Phone: +31-(0)24-36-13651
Email: Ysbrand.Willink@radboudumc.nl

Investigator:
Last name: Frank Nijsen, PhD
Email: Principal Investigator

Start date: May 2023

Completion date: May 2024

Lead sponsor:
Agency: Radboud University Medical Center
Agency class: Other

Collaborator:
Agency: Quirem Medical B.V.
Agency class: Industry

Collaborator:
Agency: Terumo Medical Corporation
Agency class: Industry

Source: Radboud University Medical Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05880472