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Intratumoral Holmium Microspheres Brachytherapy for Patients With Pancreatic Cancer (SLOTH-1)

Primary Purpose

Pancreas Cancer

Status
Recruiting
Phase
Early Phase 1
Locations
Netherlands
Study Type
Interventional
Intervention
QuiremSpheres®
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreas Cancer focused on measuring Intratumoral therapy, Holmium microspheres

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Female or male aged 18 years and over.
  2. 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).

  3. 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.
  4. Life expectancy of 12 weeks or longer.
  5. World Health Organisation (WHO) Performance status 0-1.
  6. 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.
  7. Negative pregnancy test for women of childbearing potential.

Exclusion Criteria:

  1. Radiation therapy within the last 4 weeks before the start of study therapy.
  2. Calcifications in the pancreas or tumour that are highly expected to obstruct the needle tract
  3. 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.
  4. Leukocytes < 4.0 109/l and/or platelet count < 100 109/l.
  5. 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.
  6. 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.
  7. Pregnancy or breast feeding (women of child-bearing potential).
  8. Patients suffering from psychic disorders that make a comprehensive judgement impossible, such as psychosis, hallucinations and/or depression.
  9. Patients who are declared incompetent.

Sites / Locations

  • Radboud University Medical CentreRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study patients

Arm Description

All patients receive intratumoral holmium microsphere injections.

Outcomes

Primary Outcome Measures

Feasibility of intratumoral implantation of QuiremSpheres® by SPECT imaging
To establish the feasibility of intratumoral implantation of QuiremSpheres® by evaluating the averag tumour absorbed dose in Gy calculated on SPECT.

Secondary Outcome Measures

Microsphere distribution by MRI
Microsphere distribution in analysed using MRI to evaluate tumour absorbed and non-target absorbed dose.
Microsphere distribution by CT
Microsphere distribution in analysed using CT to evaluate tumour absorbed and non-target absorbed dose.
Number of treatment-related adverse events as assessed by CTCAE v4.0
Safety, expressen in Common Terminology Criteria for Adverse Events, grade 3 and higher, probably or definetely related to the implantation procedure or medical device implant is monitored 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.

Full Information

First Posted
January 2, 2022
Last Updated
January 2, 2022
Sponsor
Radboud University Medical Center
Collaborators
Quirem Medical B.V.
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1. Study Identification

Unique Protocol Identification Number
NCT05191498
Brief Title
Intratumoral Holmium Microspheres Brachytherapy for Patients With Pancreatic Cancer
Acronym
SLOTH-1
Official Title
Intratumoral Holmium Microspheres Brachytherapy for Patients With Pancreatic Cancer; a Single Center, Non-randomized, Feasiblity Study in an Open Surgical Setting - the SLOTH1 Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
December 13, 2021 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center
Collaborators
Quirem Medical B.V.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreas Cancer
Keywords
Intratumoral therapy, Holmium microspheres

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study patients
Arm Type
Experimental
Arm Description
All patients receive intratumoral holmium microsphere injections.
Intervention Type
Device
Intervention Name(s)
QuiremSpheres®
Intervention Description
Intratumoral injection of QuiremSpheres®
Primary Outcome Measure Information:
Title
Feasibility of intratumoral implantation of QuiremSpheres® by SPECT imaging
Description
To establish the feasibility of intratumoral implantation of QuiremSpheres® by evaluating the averag tumour absorbed dose in Gy calculated on SPECT.
Time Frame
At 1 week after intervention
Secondary Outcome Measure Information:
Title
Microsphere distribution by MRI
Description
Microsphere distribution in analysed using MRI to evaluate tumour absorbed and non-target absorbed dose.
Time Frame
At 1 week after intervention
Title
Microsphere distribution by CT
Description
Microsphere distribution in analysed using CT to evaluate tumour absorbed and non-target absorbed dose.
Time Frame
At 1 week after intervention
Title
Number of treatment-related adverse events as assessed by CTCAE v4.0
Description
Safety, expressen in Common Terminology Criteria for Adverse Events, grade 3 and higher, probably or definetely related to the implantation procedure or medical device implant is monitored up to 3 months after intervention.
Time Frame
Up to 3 months after intervention
Title
Tumor response by RECIST 1.1
Description
Tumor response to the intervention is evaluated according to the Response evaluation criteria in solid tumors (RECIST) version 1.1 after 3 months.
Time Frame
At 3 months after 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. 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ysbrand Willink, MSc
Phone
+31-(0)36-2413651
Email
Ysbrand.Willink@radboudumc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank Nijsen, PhD
Organizational Affiliation
Associate professor
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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Intratumoral Holmium Microspheres Brachytherapy for Patients With Pancreatic Cancer

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