Pancreas CancerSLOTH-1NCT05191498
Intratumoral Holmium Microspheres Brachytherapy for Patients With Pancreatic Cancer
A study testing QuiremSpheres® in people with Pancreas Cancer, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
This is a feasibility study in which patients with pancreatic cancer are treated with intratumoral holmium microsphere injections. 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?
- QuiremSpheres®
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteNetherlands
- Study dates
- 13 Dec 2021to 18 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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.
- Diagnosis of primary (borderline) resectable pancreatic cancer by Dutch Pancreatic Cancer Group (DPCG) guidelines:
- 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.
- 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.
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- 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.
Who cannot join
- 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.
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- 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
About this study
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
This is a feasibility study in which patients with pancreatic cancer are treated with intratumoral holmium microsphere injections.
- Conditions
- Pancreas Cancer
- Being tested
- QuiremSpheres®
- Keywords
- Intratumoral therapy, Holmium 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.
QuiremSpheres®Device
Intratumoral injection of QuiremSpheres® up to a dose of 150 Gy.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: QuiremSpheres® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 1 week after intervention
Secondary outcomes (4)
Microsphere distribution by MRI
Microsphere distribution in analysed using MRI to evaluate tumour absorbed and non-target absorbed dose.
Measured: At 1 week after intervention
Microsphere distribution by CT
Microsphere distribution in analysed using CT to evaluate tumour absorbed and non-target absorbed dose.
Measured: At 1 week after intervention
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.
Measured: Up to 3 months after intervention
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.
Measured: At 3 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start13 Dec 2021
- Primary completion18 Feb 2024
- Study completion18 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas CancerStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Quirem Medical B.V.
- Responsible party
- Sponsor
- Investigators
- Frank Nijsen, PhD, Principal investigator, Associate professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05191498
- Sponsor's protocol ID
- NL76311.091.20
- Acronym
- SLOTH-1
- Status last verified
- May 2023
- First submitted
- 2 Jan 2022
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05191498
- Acronym / sponsor ID
- SLOTH-1 / NL76311.091.20
- Conditions
- Pancreas Cancer
- Keywords
- Intratumoral therapy, Holmium microspheres
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Quirem Medical B.V.
- Study start
- 13 Dec 2021 (actual)
- Primary completion
- 18 Feb 2024 (actual)
- Study completion
- 18 Feb 2024 (actual)
- First posted
- 13 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a feasibility study in which patients with pancreatic cancer are treated with intratumoral holmium microsphere injections.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study patients | Experimental | Device: QuiremSpheres®All patients receive intratumoral holmium microsphere injections ones, if surgery is suspended. Patient specific treamtent planning is performed for every individual patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Female or male aged 18 years and over.
- Diagnosis of primary (borderline) resectable pancreatic cancer by Dutch Pancreatic Cancer Group (DPCG) guidelines:
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuiremSpheres®Intratumoral injection of QuiremSpheres® up to a dose of 150 Gy. | Device | Study patients |
Primary outcome
Average tumour dose by SPECT imaging
Time frame: At 1 week after intervention
To establish the feasibility of intratumoral implantation of QuiremSpheres® by evaluating the average tumour absorbed dose in Gy calculated on SPECT.
4 secondary outcomes
Microsphere distribution by MRI
Time frame: At 1 week after intervention
Microsphere distribution by CT
Time frame: At 1 week after intervention
Number of treatment-related adverse events as assessed by CTCAE v4.0
Time frame: Up to 3 months after intervention
Tumor response by RECIST 1.1
Time frame: At 3 months after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank Nijsen, PhD principal investigator
Associate professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing QuiremSpheres® 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 9 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: finished, as of the sponsor's last update on 11 Apr 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 by SPECT imaging (time frame: At 1 week after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Apr 2024.