Percutaneous Holmium Injection in Pancreatic Cancer

NCT05880472 | Active Not Recruiting

• 1 other identifier: NL.82292.091.22
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

This investigator initiated study with a medical device aims to assess the safety and feasibility of percutaneous injected holmium-166 microsphere brachytherapy in patients with irresectable pancreatic cancer.

Conditions

Pancreas Cancer

Keywords

Intratumoral therapy; Brachytherapy; Holmium-166; Holmium-166 microspheres

Outcome Measures

Primary Outcomes (2)

• Average tumour dose (Gy) by SPECT/CT

  Tumour and non-tumour dose is estimated by SPECT using after intervention to assess feasibility.

  Within 24 hours post-intervention

• Number of adverse event per patient per grade by CTCAE v5.0

  Number and grade of adverse events per patient by Common Terminology Criteria for Adverse Events (CTCAE v5.0) between grade 0 (mild complication) to grade 5 (death) deemed 'unlikely', 'probably', or 'definitely' related to the implantation procedure or medical device implanted.

  Up to 16 weeks post-intervention

Secondary Outcomes (6)

• Average tumour dose (Gy) by MRI quantification

  <24 hour and 16 weeks post-intervention

• Average tumour dose (Gy)by CT quantification

  <24 hour and 16 weeks post-intervention

• Microsphere distribution (percentage covered) of 3D target area

  <24 hour and 16 weeks post-intervention

• Injection percentage (%)

  Immediately after the intervention

• Needle tip position off-target (mm)

  Immediately after the intervention

Other Outcomes (3)

• Tumor response by RECIST 1.1

  16 weeks post-intervention

• Pain-scale assessment by Numeric Pain Rating Scale (NRS)

  Up to 16 weeks post-intervention

• Implantation experience by questionnaire to the operator

  Immediately after the intervention

Study Arms (1)

Intervention arm

EXPERIMENTAL

Single or multiple injections of holmium-166 microspheres (up to 150 Gy) in a single session. Intervention is not repeated.

Device: Intratumoral

Interventions

Intratumoral DEVICE

Comparable to CE-marked QuiremSpheres(R) outside of intended use with minor altered specification.

Also known as: Intratumoural holmium-166 microspheres

Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female or male aged 18 years and over.
• Pathologically proven pancreatic adenocarcinoma, also known as pancreatic ductal adenocarcinoma.
• Patient is deemed ineligible for surgical resection of the pancreatic cancer:
• in accordance with consensus at the multidisciplinary meetings/discussions,
• and/or the patient refuses to undergo surgical resection out of personal choice
• Life expectancy of 16 weeks or longer.
• World Health Organisation (WHO) Performance status 0-1
• One or more measurable pancreatic tumours of at least 20 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.

You may not qualify if:

• Radiation therapy within the last 4 weeks before the start of study therapy.
• Chemotherapy within the last 2 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 ≥ grade 3 from the National Cancer Institute (NCI), Common Terminology Criteria for Adverse Events (CTCAE version 5.0) from previous anti-cancer therapy.
• Leukocytes \< 3.0 10\^9/l and/or platelet count \< 75 10\^9/l.
• Kidney failure: Creatine \> 165 µmol/l and/or eGFR \< 60 ml/min/1,73m\^2
• 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, interventional radiologist, radiologist, and researcher) due to tumour anatomy, nearby structures, patient status or a combination.
• 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.

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Quirem Medical B.V.: collaborator
• Terumo Medical Corporation: collaborator

Study Sites (1)

Radboud University Medical Centre

Nijmegen, Gelderland, 6525GA, Netherlands

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Frank Nijsen, PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2023
• First Posted: May 30, 2023
• Study Start: May 1, 2023
• Primary Completion: April 22, 2025
• Study Completion: April 22, 2025
• Last Updated: February 11, 2025

Record last verified: 2025-02

Locations

NL (1)