To test the feasibility and safety of minimally invasive CT-guided percutaneous holmium-166 microsphere brachytherapy in patients suffering from irresectable pancreatic cancer.
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
- Endocrine neoplasms malignant and unspecified
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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. Safety is evaluated using the
Common Terminology Criteria for Adverse Events (CTCAE v5.0).
Secondary outcome
As exploratory endpoints, tumour response (RECIST1.1), microsphere distribution
by MRI and CT, pain (NRS) and Quality of Life is evaluated. Total follow-up is
16 weeks.
Background summary
Pancreatic cancer holds one of the worst prognosis of all known malignancies.
In over 80% of cases curative resection of the tumour is not possible due to
metastases or local advancement, and only intensive palliative chemotherapy or
best-supportive care remains. Patients suffering from locally advanced
pancreatic cancer may benefit from local ablative or radiation therapies which
may improve local tumour control, pain, quality of life and survival. Minimally
invasive intratumoural injection of beta-minus (β-) emitting 166-holmium
microspheres (micro brachytherapy) may be feasible for patients with locally
irresectable pancreatic cancer.
Study 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.
Intervention
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.
Study burden and risks
Patients eligible for inclusion need to undergo additional imaging, one CT and
MRI before intervention, one SPECT, CT and MRI within 1 week after
intervention, one CT and MRI 16 weeks after intervention. The patients undergo
additional CT during HoMS implantation, which increases the radiation dose;
however, this is negligible when compared with the absorbed tumour-dose from
the HoMS. Patients are required to fill in questionnaires before and after
intervention, which is combined, if possible, in a second trial (PACAP,
NCT03513705) to prevent overlap in patient burden. Patients who receive the
study intervention have an increased risk of pancreatitis, gastro-intestinal
bleeding, fistula, jaundice or local infection. This may cause discomforts
including fatigue, nausea, emesis, diarrhoea, abdominal pain or fever.
Symptomatic discomforts can be treated if possible. Clear benefits are the
fulfilment of a treatment wish and the contribution to the development of a new
treatment for pancreatic cancer in future patients. Although benefits cannot be
assured and depend on multiple factors, benefits may include: pain reduction,
increased life expectancy, increased local tumour control, tumour shrinkage,
downstaging and resection.
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL82292.091.22 |