The main objective of this project is to demonstrate the feasibility and safety of real-time imaged radioembolisation with holmium microspheres.
ID
Source
Brief title
Condition
- Hepatobiliary neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To determine the feasibility of real-time MR imaged administration of Ho-166
microspheres in patients.
Secondary outcome
Not applicable.
Background summary
Each year, worldwide over 600,000 people develop hepatocellular carcinoma (HCC)
and cancer of the biliary tree, while at least as much are diagnosed with liver
metastases, often originating from tumours arising in organs drained by the
portal vein such as the colon. Radioembolisation, also called Selective
Intra-arterial Radionuclide Therapy (SIRT), is a technique where radioactive
microspheres are injected in the liver artery that supplies the tumour, where
they lodge in the tumour microvasculature, delivering radiation locally to the
tumour. In order to be able to better visualise the distribution of
microspheres, SIRT microspheres with gamma emission and paramagnetic properties
were developed. By administering holmium-microspheres (Ho-166-PLLA-MS) inside
an MRI-scanner, the clinician can verify the distribution of microspheres in
the liver while administering the microspheres, thus improving treatment
understanding.
Study objective
The main objective of this project is to demonstrate the feasibility and safety
of real-time imaged radioembolisation with holmium microspheres.
Study design
This is a single centre, interventional treatment, non-randomized, open label,
feasibility study with a medical device in 6 patients.
Patient will undergo interventional radiological placement of an MR opaque
catheter, after which the patient is moved to the MRI, where administration of
microspheres is performed in stages under real time MRI.
Intervention
Ho-166-PLLA-MS will be administered via a catheter during MR imaging.
Study burden and risks
It is anticipated that treatment with radioactive microspheres will reduce
tumour size and will improve quality of life as known from literature from
holmium-166 and yttrium-90 SIRT. Treatment is as per usual, with the only
difference of real time imaging during administration. The intra-arterial
access procedure will be as usual, however, the patient will be transferred to
the MR table and moved to the MRI facility adjacent to the AngioSuite. The
patient will undergo several MR scans of approximately 90 minutes while and
after microspheres are administered. If MR imaged administration is not deemed
feasible for any reason, administration will take place as usual, under X-ray
imaging.
For treatment within this study, a total of 7 visits is required, of which 6
are part of regular patient care. The seventh visit is a screening visit at
which the patient will be asked to participate in the study. Health related
Quality of Life assessments are required at 4 visits. Multiple diagnostic scans
will be performed outside regular patient care, with modalities using
non-ionizing radiation. If feasibility can be demonstrated, better
understanding of microsphere deposition can lead to more personalized treatment
for future cohorts, likely resulting in more effective treatment.
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
1. Patients must have given written informed consent.
2. Female or male aged 18 years and over.
3. Diagnosis of hepatocellular carcinoma or cholangiocarcinoma in the liver or diagnosis of metastatic malignancy to the liver with limited disease outside the liver (i.e. liver-dominant disease) defined as the sum of the diameters of all metastases in the liver be more than 200% of the sum of the diameters of all soft tissue lesions outside the liver.
4. Patient is not amenable for standard therapies (other than radioembolisation) or patient refuses standard therapies
5. Life expectancy of 12 weeks or longer.
6. World Health Organisation (WHO) Performance status 0-1 (see Appendix III).
7. One or more measurable lesions of at least 10 mm in the longest diameter by spiral CT according to the Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 criteria.
8. Negative pregnancy test for women of childbearing potential.
Exclusion criteria
1. Brain metastases or spinal cord compression, unless irradiated at least 4 weeks prior to the date of the experimental treatment and stable without steroid treatment for at least 1 week
2. Radiation therapy within the last 4 weeks before the start of study therapy.
3. The last dose of prior systemic therapy has been received less than 4 weeks prior the start of study therapy.
4. Major surgery within 4 weeks, or incompletely healed surgical incision before starting study therapy.
5. Any unresolved toxicity greater than National Cancer Institute (NCI), Common Terminology Criteria for Adverse Events (CTCAE version 4.0, see Appendix II) grade 2 from previous anti-cancer therapy.
6. Serum bilirubin > 1.5 x Upper Limit of Normal (ULN).
7. Glomerular filtration rate <35 ml/min, determined according to the Modification of Diet in Renal Disease formula.
8. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) > 5 x ULN.
9. Leukocytes < 4.0 10^9/l and/or platelet count < 150 10^9/l.
10. 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.
11. Pregnancy or breast feeding (women of child-bearing potential).
12. Patients suffering from diseases with an increased chance of liver toxicity, such as primary biliary cirrhosis or xeroderma pigmentosum.
13. Patients suffering from psychic disorders that make a comprehensive judgement impossible, such as psychosis, hallucinations and/or depression.
14. Patients ineligible to undergo MR imaging.
15. Patients who are claustrophobic.
16. Patient who had prior liver resection and/or coil placement inside the liver, expected to cause imaging artefacts on MRI that will limit MR quantification.
17. Patients who are declared incompetent.
18. Previous enrolment in the present study or previous treatment with radioembolisation.
19. Portal vein thrombosis (tumour and/or bland) of the main branch (diagnosed on contrast enhanced transaxial images). Involvement of the right or left portal vein branches and more distal is accepted.
20. Evidence of untreated, clinically significant grade 3 portal hypertension (i.e. large varices at oesophago-gastro-duodenoscopy). In these cases, therapy with non-selective beta blocker (propranolol) or rubber band ligation should be instituted according to accepted guidelines. In case of small varices, prophylactic propranolol is advised.
21. Untreated active hepatitis.
22. Transjugular intrahepatic portosystemic shunt (TIPS).
23. Body weight over 150 kg (because of maximum table load).
24. Severe allergy for intravenous contrast agents used
a. Iomeron®, because of CT evaluation, pre-treatment angiography and treatment angiography.
b. Dotarem or Primovist, depending on the agent used at the time of treatment
25. Lung shunt >30 Gy, as calculated using scout dose SPECT/CT.
26. Uncorrectable extrahepatic deposition of scout dose activity. Activity in the falciform ligament, portal lymph nodes and gallbladder is accepted.
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 | NL68354.091.18 |