Intratumoral Holmium Microspheres Brachytherapy for Patients With Pancreatic Cancer

NCT ID: NCT05191498

Last Updated: 2024-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-13
• Study Completion Date: 2024-02-18

Brief Summary

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

Conditions

Pancreas Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study patients

All patients receive intratumoral holmium microsphere injections ones, if surgery is suspended. Patient specific treamtent planning is performed for every individual patient.

Group Type: EXPERIMENTAL

QuiremSpheres®

Intervention Type: DEVICE

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

Interventions

QuiremSpheres®

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Quirem Medical B.V.

INDUSTRY

Sponsor Role: collaborator

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frank Nijsen, PhD

Role: PRINCIPAL_INVESTIGATOR

Associate professor

Locations

Radboud University Medical Centre

Nijmegen, Gelderland, Netherlands

Countries

Netherlands

Other Identifiers

NL76311.091.20

Identifier Type: -

Identifier Source: org_study_id