Percutaneous intratumoural holmium microspheres brachytherapy for patients with pancreatic cancer; a single centre, prospective safety and feasibility study

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 6

Inclusion Criteria

1. Female or male aged 18 years and over.
2. Pathologically proven pancreatic adenocarcinoma, also known as pancreatic
ductal adenocarcinoma.
3. Patient is deemed ineligible for surgical resection of the pancreatic cancer:
a. in accordance with consensus at the multidisciplinary meetings/discussions,
b. and/or the patient refuses to undergo surgical resection out of personal
choice
4. Life expectancy of 16 weeks or longer.
5. World Health Organisation (WHO) Performance status 0-1
6. 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.
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. Chemotherapy within the last 2 weeks before the start of study therapy.
3. Calcifications in the pancreas or tumour that are highly expected to
obstruct the needle tract
4. 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.
5. Leukocytes < 3.0 109/l and/or platelet count < 75 109/l.
6. Kidney failure: Creatine > 165 µmol/l and/or eGFR < 60 ml/min/1,73m2
7. Significant cardiac event 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.
8. 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.
9. Pregnancy or breast feeding (women of child-bearing potential).
10. Patients suffering from psychic disorders that make a comprehensive
judgement impossible, such as psychosis, hallucinations and/or depression.
11. Patients who are declared incompetent.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main endpoint is to establish the feasibility and safety of CT-guided<br /><br>percutaneous intratumoural implantation of HoMS in irresectable pancreatic<br /><br>adenocarcinoma. Feasibility is established by evaluating the average tumour<br /><br>absorbed dose in Gray (Gy) calculated on SPECT. Safety is evaluated using the<br /><br>Common Terminology Criteria for Adverse Events (CTCAE v5.0).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>As exploratory endpoints, tumour response (RECIST1.1), microsphere distribution<br /><br>by MRI and CT, pain (NRS) and Quality of Life is evaluated. Total follow-up is<br /><br>16 weeks.</p><br>