Clinical trial · Interventional
Percutaneous Holmium Injection in Pancreatic Cancer
Percutaneous Intratumoural Holmium Microspheres Brachytherapy for Patients With Pancreatic Cancer; a Single Centre, Prospective Safety and Feasibility Study
NCT05880472CI-TRIAL-00085779SLOTH-2aactive not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreas Cancer | Pancreatic Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intratumoral | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intervention arm
- description
- Single or multiple injections of holmium-166 microspheres (up to 150 Gy) in a single session. Intervention is not repeated.
- interventionNames
- Device: Intratumoral
Primary outcomes (2)
- measure
- Average tumour dose (Gy) by SPECT/CT
- timeFrame
- Within 24 hours post-intervention
- description
- Tumour and non-tumour dose is estimated by SPECT using after intervention to assess feasibility.
- measure
- Number of adverse event per patient per grade by CTCAE v5.0
- timeFrame
- Up to 16 weeks post-intervention
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.