Intratumoral Holmium Microspheres Brachytherapy for Patients With Pancreatic Cancer

Study Overview
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Brief Summary
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This is a feasibility study in which patients with pancreatic cancer are treated with intratumoral holmium microsphere injections.

Official Title
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Intratumoral Holmium Microspheres Brachytherapy for Patients With Pancreatic Cancer; a Single Center, Non-randomized, Feasiblity Study in an Open Surgical Setting - the SLOTH1 Study

Conditions
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Pancreas Cancer

Intervention / Treatment
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* Device: QuiremSpheres®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female or male aged 18 years and over. Diagnosis of primary (borderline) resectable pancreatic cancer by Dutch Pancreatic Cancer Group (DPCG) guidelines: i. 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. iii. 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. Exclusion Criteria: Radiation therapy within the last 4 weeks before the start of study therapy. Calcifications in the pancreas or tumour that are highly expected to obstruct the needle tract 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. Leukocytes < 4.0 109/l and/or platelet count < 100 109/l. 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. 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 suffering from psychic disorders that make a comprehensive judgement impossible, such as psychosis, hallucinations and/or depression. Patients who are declared incompetent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study patients<br>All patients receive intratumoral holmium microsphere injections. | Device: QuiremSpheres®<br>* Intratumoral injection of QuiremSpheres®<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of intratumoral implantation of QuiremSpheres® by SPECT imaging | To establish the feasibility of intratumoral implantation of QuiremSpheres® by evaluating the averag tumour absorbed dose in Gy calculated on SPECT. | At 1 week after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microsphere distribution by MRI | Microsphere distribution in analysed using MRI to evaluate tumour absorbed and non-target absorbed dose. | At 1 week after intervention | 
| Microsphere distribution by CT | Microsphere distribution in analysed using CT to evaluate tumour absorbed and non-target absorbed dose. | At 1 week after intervention | 
| Number of treatment-related adverse events as assessed by CTCAE v4.0 | Safety, expressen in Common Terminology Criteria for Adverse Events, grade 3 and higher, probably or definetely related to the implantation procedure or medical device implant is monitored up to 3 months after intervention. | Up to 3 months after intervention | 
| Tumor response by RECIST 1.1 | Tumor response to the intervention is evaluated according to the Response evaluation criteria in solid tumors (RECIST) version 1.1 after 3 months. | At 3 months after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intratumoral therapy, Holmium microspheres