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Pancreas CancerSLOTH-2aNCT05880472

Percutaneous Holmium Injection in Pancreatic Cancer

A study testing Intratumoral in people with Pancreas Cancer, run by Radboud University Medical Center at 1 site in Netherlands.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreas Cancer
What is being tested?
Intratumoral
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteNetherlands
Study dates
1 May 2023to 22 Apr 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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
Show all 11Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Radboud University Medical Centre

    Nijmegen, Gelderland, 6525GA

Other trials in Netherlands

About this study

Official title: Percutaneous Intratumoural Holmium Microspheres Brachytherapy for Patients With Pancreatic Cancer; a Single Centre, Prospective Safety and Feasibility Study

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.

Read the detailed description

Objective: To test the feasibility and safety of minimally invasive CT-guided percutaneous holmium-166 microsphere brachytherapy in patients suffering from irresectable pancreatic cancer. Study design: This is a single centre, prospective, safety and feasibility study with a medical device in a maximum of 6 patients.

Study population: Patients diagnosed with pathologically proven pancreatic adenocarcinoma, who are ineligible for exploratory surgery or surgical resection of the tumour after 8 cycles of systemic therapy or less in case of unacceptable toxicity, patient refusal or patients who are ineligible for systematic therapy.

Intervention (if applicable): A radioactive medical device will be implanted by CT-guided percutaneous injection. The medical device in question are beta-minus (β-) and gamma(γ) emitting holmium-166 poly(L-lactic acid) microspheres (166Ho-PLLA-MS, HoMS) in a 0.1% Pluronic or cellulose based suspension.

Main study parameters/endpoints: The main endpoint is to establish the feasibility and safety of CT-guided percutaneous intratumoural implantation of HoMS in irresectable pancreatic adenocarcinoma. Feasibility is established by evaluating the average tumour absorbed dose in Gray (Gy) calculated on SPECT and comparing to the pre-operative planning. Intratumoural microsphere distribution, absorbed tumour dose and non-target absorbed tumour dose are analysed using MRI and CT quantification. Safety is evaluated using the Common Terminology Criteria for Adverse Events (CTCAE v5.0), events deemed 'unlikely', 'probably' or 'definitely' related to the implantation procedure or implanted medical device. As exploratory endpoints, tumour response (RECIST1.1), pain (NRS) and Quality of Life is evaluated. Total follow-up is 16 weeks.

Conditions
Pancreas Cancer
Being tested
Intratumoral
Keywords
Intratumoral therapy, Brachytherapy, Holmium-166, Holmium-166 microspheres
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IntratumoralDevice

    Also called Intratumoural holmium-166 microspheres

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

Study groups in NCT05880472
Study groupRoleWhat they receive
Intervention armExperimentalSingle or multiple injections of holmium-166 microspheres (up to 150 Gy) in a single session. Intervention is not repeated.
Receives: Device: Intratumoral

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Average tumour dose (Gy) by SPECT/CT

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

    Measured: Within 24 hours post-intervention

  2. 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.

    Measured: Up to 16 weeks post-intervention

Secondary outcomes (6)

  1. Average tumour dose (Gy) by MRI quantification

    Measured: <24 hour and 16 weeks post-intervention

  2. Average tumour dose (Gy)by CT quantification

    Measured: <24 hour and 16 weeks post-intervention

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

    By CT or MRI to assess dose coverage

    Measured: <24 hour and 16 weeks post-intervention

  4. Injection percentage (%)

    Implant efficiency

    Measured: Immediately after the intervention

  5. Needle tip position off-target (mm)

    implant accuracy

    Measured: Immediately after the intervention

  6. Operator hand and total body dose (mSv)

    Operator safety

    Measured: Immediately after the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2023
  2. Study start1 May 2023
  3. Primary completion22 Apr 2025 (estimated)
  4. Study completion22 Apr 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05880472
Sponsor's protocol ID
NL.82292.091.22
Acronym
SLOTH-2a
Status last verified
Feb 2025
First submitted
9 May 2023
Last updated
11 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Intratumoral in people with Pancreas Cancer, run by Radboud University Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Average tumour dose (Gy) by SPECT/CT (time frame: Within 24 hours post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05880472.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2025.

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