pancreatic adenocarcinoma Pancreatic cancer
Conditions
Interventions
A radioactive medical device will be implanted by CT-guided percutaneous
injection. The medical device in question are beta-minus (&beta
-) and gamma (&gamma
)
emitting holmium-166 poly(L-lactic acid) microspheres (166Ho-PLLA-MS, HoMS) in
a 0.1% Pluronic or cellulose based suspension.
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion 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: a. in accordance with consensus at the multidisciplinary meetings/discussions, b. 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
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 165 µmol/l and/or eGFR =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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. Safety is evaluated using the Common Terminology Criteria for Adverse Events (CTCAE v5.0). | — |
Secondary
| Measure | Time frame |
|---|---|
| As exploratory endpoints, tumour response (RECIST1.1), microsphere distribution by MRI and CT, pain (NRS) and Quality of Life is evaluated. Total follow-up is 16 weeks. | — |
Countries
Netherlands
Outcome results
None listed