Intratumoral Holmium Microspheres Brachytherapy for Patients With Pancreatic Cancer (SLOTH-1)

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

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

Study Overview

• Status: Completed
• Conditions: Pancreas Cancer
• Intervention / Treatment: Device: QuiremSpheres®

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6525GA
      • Radboud University Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Female or male aged 18 years and over.

2. 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).

3. 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.
4. Life expectancy of 12 weeks or longer.
5. World Health Organisation (WHO) Performance status 0-1.
6. 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.
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. Calcifications in the pancreas or tumour that are highly expected to obstruct the needle tract
3. 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.
4. Leukocytes < 4.0 109/l and/or platelet count < 100 109/l.
5. 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.
6. 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.
7. Pregnancy or breast feeding (women of child-bearing potential).
8. Patients suffering from psychic disorders that make a comprehensive judgement impossible, such as psychosis, hallucinations and/or depression.
9. Patients who are declared incompetent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study patients; All patients receive intratumoral holmium microsphere injections ones, if surgery is suspended. Patient specific treamtent planning is performed for every individual patient.	Device: QuiremSpheres®; Intratumoral injection of QuiremSpheres® up to a dose of 150 Gy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average tumour dose by SPECT imaging	To establish the feasibility of intratumoral implantation of QuiremSpheres® by evaluating the average 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
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
Number of treatment-related adverse events as assessed by CTCAE v4.0	Safety, expressed in Common Terminology Criteria for Adverse Events, grade 3 and higher, probably or definitely related to the implantation procedure or medical device implant is monitored up to 3 months after intervention.	Up to 3 months after intervention

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Collaborators: Quirem Medical B.V.
• Investigators: Principal Investigator: Frank Nijsen, PhD, Associate professor

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2021
• Primary Completion (Actual): February 18, 2024
• Study Completion (Actual): February 18, 2024

Study Registration Dates

• First Submitted: January 2, 2022
• First Submitted That Met QC Criteria: January 2, 2022
• First Posted (Actual): January 13, 2022

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Intratumoral therapy; Holmium microspheres
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: NL76311.091.20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No