Intratumoral: Comparable to CE-marked QuiremSpheres(R) outside of intended use with minor altered specification.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Average tumour dose (Gy) by SPECT/CT — Within 24 hours post-intervention Tumour and non-tumour dose is estimated by SPECT using after intervention to assess feasibility.
Number of adverse event per patient per grade by CTCAE v5.0 — Up to 16 weeks post-intervention Number and grade of adverse events per patient by Common Terminology Criteria for Adverse Events (CTCAE v5.0) between grade 0 (mild complication) to grade 5 (death) deemed 'unlikely', 'probably', or 'definitely' related to the implantation procedure or medical device implanted.
Trial sites (1)
Facility
City
Region
Status
Radboud University Medical Centre
Nijmegen
Gelderland
More Radboud University Medical Center trials in the Netherlands
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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