Back to resultsPercutaneous Holmium Injection in Pancreatic Cancer (SLOTH-2a)
Primary Purpose
Pancreas Cancer
Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Intratumoral
Sponsored by
About this trial
This is an interventional treatment trial for Pancreas Cancer focused on measuring Intratumoral therapy, Brachytherapy, Holmium-166, Holmium-166 microspheres
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Sites / Locations
- Radboud University Medical CentreRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention arm
Arm Description
Single or multiple injections of holmium-166 microspheres (up to 150 Gy) in a single session. Intervention is not repeated.
Outcomes
Primary Outcome Measures
Average tumour dose (Gy) by SPECT/CT
Tumour and non-tumour dose is estimated by SPECT using after intervention to assess feasibility.
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) deemed 'unlikely', 'probably', or 'definitely' related to the implantation procedure or medical device implanted.
Secondary Outcome Measures
Average tumour dose (Gy) by MRI quantification
Average tumour dose (Gy)by CT quantification
Microsphere distribution (percentage covered) of 3D target area
By CT or MRI to assess dose coverage
Injection percentage (%)
Implant efficiency
Needle tip position off-target (mm)
implant accuracy
Operator hand and total body dose (mSv)
Operator safety
Full Information
NCT ID
NCT05880472
First Posted
May 9, 2023
Last Updated
May 19, 2023
Sponsor
Radboud University Medical Center
Collaborators
Quirem Medical B.V., Terumo Medical Corporation
1. Study Identification
Unique Protocol Identification Number
NCT05880472
Brief Title
Percutaneous Holmium Injection in Pancreatic Cancer
Acronym
SLOTH-2a
Official Title
Percutaneous Intratumoural Holmium Microspheres Brachytherapy for Patients With Pancreatic Cancer; a Single Centre, Prospective Safety and Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 2023 (Anticipated)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center
Collaborators
Quirem Medical B.V., Terumo Medical Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreas Cancer
Keywords
Intratumoral therapy, Brachytherapy, Holmium-166, Holmium-166 microspheres
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
Single or multiple injections of holmium-166 microspheres (up to 150 Gy) in a single session. Intervention is not repeated.
Intervention Type
Device
Intervention Name(s)
Intratumoral
Other Intervention Name(s)
Intratumoural holmium-166 microspheres
Intervention Description
Comparable to CE-marked QuiremSpheres(R) outside of intended use with minor altered specification.
Primary Outcome Measure Information:
Title
Average tumour dose (Gy) by SPECT/CT
Description
Tumour and non-tumour dose is estimated by SPECT using after intervention to assess feasibility.
Time Frame
Within 24 hours post-intervention
Title
Number of adverse event per patient per grade by CTCAE v5.0
Description
Number and grade of adverse events per patient by Common Terminology Criteria for Adverse Events (CTCAE v5.0) deemed 'unlikely', 'probably', or 'definitely' related to the implantation procedure or medical device implanted.
Time Frame
Up to 16 weeks post-intervention
Secondary Outcome Measure Information:
Title
Average tumour dose (Gy) by MRI quantification
Time Frame
<24 hour and 16 weeks post-intervention
Title
Average tumour dose (Gy)by CT quantification
Time Frame
<24 hour and 16 weeks post-intervention
Title
Microsphere distribution (percentage covered) of 3D target area
Description
By CT or MRI to assess dose coverage
Time Frame
<24 hour and 16 weeks post-intervention
Title
Injection percentage (%)
Description
Implant efficiency
Time Frame
Immediately after the intervention
Title
Needle tip position off-target (mm)
Description
implant accuracy
Time Frame
Immediately after the intervention
Title
Operator hand and total body dose (mSv)
Description
Operator safety
Time Frame
Immediately after the intervention
Other Pre-specified Outcome Measures:
Title
Tumor response by RECIST 1.1
Time Frame
16 weeks post-intervention
Title
Pain-scale assessment by Numeric Pain Rating Scale (NRS)
Description
Scale from 0 to 10 of average and worst pain with 0 no pain and 10 worst possible pain
Time Frame
Up to 16 weeks post-intervention
Title
Implantation experience by questionnaire to the operator
Time Frame
Immediately after the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ysbrand CY Willink, MSc
Phone
+312436-13651
Email
Ysbrand.Willink@radboudumc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank Nijsen, PhD
Organizational Affiliation
Radboud University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radboud University Medical Centre
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6525GA
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ysbrand Willink, MSc
Phone
+31-(0)24-36-13651
Email
Ysbrand.Willink@radboudumc.nl
First Name & Middle Initial & Last Name & Degree
Frank Nijsen, PhD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Percutaneous Holmium Injection in Pancreatic Cancer
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