Intratumoral Holmium Microspheres Brachytherapy for Patients With Pancreatic Cancer

Pancreas Cancer Clinical Trial

— SLOTH-1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05191498
• Other study ID #: NL76311.091.20
• Status: Completed
• Phase: N/A
• Start date: December 13, 2021
• Est. completion date: February 18, 2024

Study information

• Verified date: May 2023
• Source: Radboud University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: February 18, 2024
• Est. primary completion date: February 18, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pancreas Cancer
• Pancreatic Neoplasms

Intervention

Device:
• QuiremSpheres®
Intratumoral injection of QuiremSpheres® up to a dose of 150 Gy.

Locations

Country	Name	City	State
Netherlands	Radboud University Medical Centre	Nijmegen	Gelderland

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University Medical Center	Quirem Medical B.V.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Microsphere distribution by MRI	Microsphere distribution in analysed using MRI to evaluate tumour absorbed and non-target absorbed dose.	At 1 week after intervention
Secondary	Microsphere distribution by CT	Microsphere distribution in analysed using CT to evaluate tumour absorbed and non-target absorbed dose.	At 1 week after intervention
Secondary	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
Secondary	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