NCT05880472Active, not recruiting
Percutaneous Holmium Injection in Pancreatic Cancer
Percutaneous Intratumoural Holmium Microspheres Brachytherapy for Patients With Pancreatic Cancer; a Single Centre, Prospective Safety and Feasibility Study
Source: ClinicalTrials.gov · Last updated 11 Feb 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 6 (actual)
- First submitted
- 9 May 2023
- Start date
- 1 May 2023
- Primary completion date
- 22 Apr 2025
- Lead sponsor
- Radboud University Medical Center
- Diseases
- Pancreatic cancer
- NCT number
- NCT05880472
What you commit to
- Study type: Interventional
- Participants enrolled: 6
- From 1 May 2023 to the primary completion date, 22 Apr 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Radiation therapy within the last 4 weeks before the start of study therapy.
- Chemotherapy within the last 2 weeks before the start of study therapy.
- 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.
- 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.
Other illness
- Patients suffering from psychic disorders that make a comprehensive judgement impossible, such as psychosis, hallucinations and/or depression.
Lab values
- Leukocytes \< 3.0 10\^9/l and/or platelet count \< 75 10\^9/l.
- Kidney failure: Creatine \> 165 µmol/l and/or eGFR \< 60 ml/min/1,73m\^2
Other
- Calcifications in the pancreas or tumour that are highly expected to obstruct the needle tract
- 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.
- Pregnancy or breast feeding (women of child-bearing potential).
- Patients who are declared incompetent.
Who the study is looking for
- Female or male aged 18 years and over.
- Pathologically proven pancreatic adenocarcinoma, also known as pancreatic ductal adenocarcinoma.
- Patient is deemed ineligible for surgical resection of the pancreatic cancer:
- in accordance with consensus at the multidisciplinary meetings/discussions,
- and/or the patient refuses to undergo surgical resection out of personal choice
- Life expectancy of 16 weeks or longer.
- World Health Organisation (WHO) Performance status 0-1
- 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.
- Negative pregnancy test for women of childbearing potential.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Radboud university medical centre Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.