To investigate the in vivo performance and safety of a novel medical device for the injection of holmium-166 microspheres during SIRT. This main potential advantage of this device is that it allows for injection of a during treatment determined dose…
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To determine technical performance and accuracy of a novel injection device for
SIRT. Additionally, the safety of the device will be assessed.
Secondary outcome
To perform dosimetry based on MRI and SPECT imaging of holmium-166 and
correlate this to tumour response. To investigate the potential added value of
gated 166Ho-SPECT/CT compared to conventional 166Ho-SPECT/CT . To investigate
the added value of a novel reconstruction algorithm for cone-beam CT (CAVAREC)
that compensates for motion during CT acquisition. Local response evaluation at
3 months after treatment through contrast-enhanced MRI and/or contrast-enhanced
CT, according to mRECIST/RECIST 1.1 criteria (depending on tumour type).
Background summary
Selective internal radiation therapy (SIRT) is a treatment for liver cancer
during which radioactive microspheres are injected into the hepatic artery
through a catheter under x-ray fluoroscopy image-guidance. These microspheres
are transported with the blood flow through the liver, until they get stuck in
the arterioles because of their size. This is currently not a real-time
controlled procedure, and the achieved distribution of the microspheres is only
verified days after treatment, without any consequences in case of a failed
treatment. The holmium-166 loaded microspheres used in this study can be
visualized with MRI. In the EMERITUS-study, we demonstrated the feasibility of
visualising the microsphere distribution during treatment already, potentially
allowing for MRI-guided treatment. Another prerequisite for image-guided
treatment is the ability to administer a precise, on-site determined amount of
microspheres. For this purpose, a novel injection device has been developed,
that will be validated in this clinical study.
Study objective
To investigate the in vivo performance and safety of a novel medical device for
the injection of holmium-166 microspheres during SIRT. This main potential
advantage of this device is that it allows for injection of a during treatment
determined dose, which is not possible with the current administration tool.
Study design
The study design is very similar to the recently completed EMERITUS-1 study.
Patients will be treated as per usual, except that the administration of
microspheres will be performed while the patient is positioned in the bore of
an MRI scanner. Microspheres will be injected using a novel device, however,
the total injected dose and therefore treatment efficacy will be identical to
treatment outside of the study.
Intervention
Holmium-166 SIRT as per usual, with patient positioned in MRI scanner.
Injection of microspheres will be done with a novel injection device.
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 consist of injecting an identical
dose of microspheres as usual, and therefore, no differences in treatment
efficacy are expected. The additional burden consists of treatment taking place
at the MRI-scanner instead of the angio suite, as a result of which treatment
will take approximately 60-90 minutes longer than usual.
For treatment within this study, a total of 8 visits (one is a telephone call)
is required, all of which are part of regular patient care. Multiple diagnostic
scans will be performed outside regular patient care, with modalities using
non-ionizing radiation. If the new injection device performs as expected,
follow-up studies will investigate a more personalized treatment for future
cohorts, likely resulting in more effective treatment.
Geert Grooteplein Zuid 10
Nijmegen 6525GA
NL
Geert Grooteplein Zuid 10
Nijmegen 6525GA
NL
Listed location countries
Age
Inclusion criteria
1. Diagnosis of hepatocellular carcinoma or liver metastases originating from
colorectal cancer
2. At least one lesion of 10 mm in the longest diameter on contrast-enhanced
MRI or contrast-enhanced CT
3. Patient is eligible for SIRT as determined by the tumour board (in Dutch:
MDO)
4. Patient has a life expectancy of 12 weeks or longer
5. Patient has a WHO performance score of 0-2
Exclusion criteria
1. Significant extrahepatic disease (2x sum of diameters of lesions outside the
liver > sum of lesions inside the liver)
2. Radiation therapy, chemotherapy or major surgery within 4 weeks before
treatment
3. Serum bilirubin > 2.0 x the upper limit of normal
4. ALAT, ASAT, alkaline phosphatase (AF) > 5x the upper limit of normal
5. Glomerular filtration rate (GFR-MDRD) <35 ml/min
6. Leukocytes <4.0 * 10^9/L or platelet count <60 * 10^9/L
7. Significant heart disease that in the opinion of the physician increases the
risk of ventricular arrhythmia.
8. Pregnancy or breast feeding
9. Disease with increased chance of liver toxicity, such as primary biliary
cirrhosis or xeroderma pigmentosum
10. Patients ineligible to undergo MR-imaging (claustrophobia, metal implants,
etc)
11. Portal vein thrombosis of the main branch (more distal branches are allowed)
12. Evidence of clinically relevant, untreated grade 3 portal hypertension
13. Untreated, active hepatitis
14. Body weight > 150 kg (because of maximum table load)
15. Severe allergy for i.v. contrast (Iomeron, Dotarem and/or Primovist)
16. Lung shunt > 30 Gy, as calculated using scout dose holmium-166 SPECT/CT
17. Uncorrectable extrahepatic deposition of scout dose activity. Activity in
the falciform ligament, portal lymph nodes or gallbladder are 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 | NL78931.091.21 |