NCT05191498

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 13, 2021

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

January 2, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 13, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 18, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 18, 2024

Completed
Last Updated

April 11, 2024

Status Verified

May 1, 2023

Enrollment Period

2.2 years

First QC Date

January 2, 2022

Last Update Submit

April 9, 2024

Conditions

Pancreas Cancer

Keywords

Intratumoral therapyHolmium microspheres

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Microsphere distribution by MRI

    At 1 week after intervention

  • Microsphere distribution by CT

    At 1 week after intervention

  • Number of treatment-related adverse events as assessed by CTCAE v4.0

    Up to 3 months after intervention

  • Tumor response by RECIST 1.1

    At 3 months after intervention

Study Arms (1)

Study patients

EXPERIMENTAL

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

Device: QuiremSpheres®

Interventions

QuiremSpheres®DEVICE

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

Study patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University Medical Centre

Nijmegen, Gelderland, 6525GA, Netherlands

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Frank Nijsen, PhD

    Associate professor

    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

January 2, 2022

First Posted

January 13, 2022

Study Start

December 13, 2021

Primary Completion

February 18, 2024

Study Completion

February 18, 2024

Last Updated

April 11, 2024

Record last verified: 2023-05

Locations

NL(1)