NCT05191498Completed
Intratumoral Holmium Microspheres Brachytherapy for Patients With Pancreatic Cancer
Intratumoral Holmium Microspheres Brachytherapy for Patients With Pancreatic Cancer; a Single Center, Non-randomized, Feasibility Study in an Open Surgical Setting - the SLOTH1 Study
Source: ClinicalTrials.gov · Last updated 11 Apr 2024
Brief summary (registry, in English)
This is a feasibility study in which patients with pancreatic cancer are treated with intratumoral holmium microsphere injections.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 3 (actual)
- First submitted
- 2 Jan 2022
- Start date
- 13 Dec 2021
- Primary completion date
- 18 Feb 2024
- Lead sponsor
- Radboud University Medical Center
- Diseases
- Pancreatic cancer
- NCT number
- NCT05191498
What you commit to
- Study type: Interventional
- Participants enrolled: 3
- From 13 Dec 2021 to the primary completion date, 18 Feb 2024
- 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.
- Any unresolved toxicity greater than National Cancer Institute (NCI), Common Terminology Criteria for Adverse Events (CTCAE version 4.0) grade 2 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 \< 4.0 109/l and/or platelet count \< 100 109/l.
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 and researcher) due to tumour anatomy or nearby structures.
- 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.
- Diagnosis of primary (borderline) resectable pancreatic cancer by Dutch Pancreatic Cancer Group (DPCG) guidelines:
- 1o-90o contact between tumor and the superior mesenteric artery, celiac axis or common hepatic artery. Or; ii. 90o-270o contact between tumor and superior mesenteric vein or portal vein, without occlusion.
- The discussion on resectability has to be made in consensus at multidisciplinary meetings/discussions and may overrule the above criteria (i, ii).
- Patient is deemed eligible for surgical resection of the pancreatic cancer, however, during open surgery a more advanced disease than initially anticipated is found and resection is no longer feasible.
- Life expectancy of 12 weeks or longer.
- World Health Organisation (WHO) Performance status 0-1.
- One or more measurable lesions of at least 10 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.