This trial will be a first-in-man study. It should therefore demonstrate the feasibility and accuracy of liver tumor ablation. Since image-guided tumor ablation techniques, such as MR-HIFU, leave the coagulated tumor in situ, treatment accuracy is…
ID
Source
Brief title
Condition
- Hepatobiliary neoplasms malignant and unspecified
- Metastases
- Hepatobiliary therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective of this first-in-man study is to investigate the accuracy
of MR-HIFU ablation of metastatic liver tumors. The accuracy is assessed by
comparing: I) ablated tissue volume, visualized as non-perfused volume on
contrast-enhanced MR imaging after HIFU treatment; II) thermal dose as measured
by MR thermometry during treatment; III) the necrotic tissue volume in the
surgical resection specimen. In addition, the quality of the ablated tissue
volume will be assessed.
Thus, complete tumor ablation is not required for this study; tumor size is
therefore of lesser importance.
Secondary outcome
To assess the safety of MR-HIFU liver tumor ablation in the patient population
as described in chapter 6.1. Therefore, I) any minor or major complications
will be recorded; and III) liver function tests (LFTs) in blood plasma will be
measured before and after the procedure and before surgical resection of the
tumor (to assess the biochemical effects of MR-HIFU liver tumor ablation).
In addition, it is important to collect data regarding patient eligibility for
MR-HIFU treatment. Patients can be considered not eligible for the MR-HIFU
procedure based on computer treatment simulations. These simulations are
performed using the pre-treatment MRI scan that patients undergo approximately
one week before treatment (see also chapter 3.2). For each patient that
participates in the study but is considered ineligible for the MR-HIFU
procedure, the reason will be recorded on a screening and enrollment log and on
the CRF.
Background summary
Metastatic liver cancer represents a significant disease burden in the western
world. Unfortunately, only a minority of patients is eligible for surgical
resection. Therefore, most patients have to rely on alternative treatment
options for improved survival and quality of life. Since sustained quality of
life is very important for patients with metastatic cancer, minimally- and
non-invasive treatment options are of particular interest. Magnetic resonance-
guided high intensity focused ultrasound (MR-HIFU) allows for image-guided,
non-invasive tumor ablation. Due to the non-invasiveness of this technique, it
can potentially improve survival of metastatic liver cancer patients while
retaining quality of life in the palliative phase.
Study objective
This trial will be a first-in-man study. It should therefore demonstrate the
feasibility and accuracy of liver tumor ablation. Since image-guided tumor
ablation techniques, such as MR-HIFU, leave the coagulated tumor in situ,
treatment accuracy is of paramount importance. This study was therefore
designed as a treat-and-resect study, in order to validate the accuracy of
tissue ablation with histopathology. This also means that complete tumor
ablation is not required, since we aim to study the accuracy of the ablated
tissue volume, not the possibility to completely ablate the tumor.
Study design
This feasibility study is designed as a single-center, single arm,
non-randomized treat-and-resect trial to evaluate the treatment accuracy and
safety of MR-HIFU in patients with metastatic liver tumors.
Intervention
MR-HIFU is used to ablate (part of) one metastatic liver tumor. HIFU ablation
uses focused ultrasound waves to non-invasively heat and thermally ablate
tissue. MR guidance is used for treatment planning, treatment monitoring
(temperature monitoring) and treatment evaluation.
Study burden and risks
After giving informed consent, patients will undergo a contrast-enhanced
pre-treatment MRI on the MR-HIFU system (first visit). This MRI will be used to
perform computer simulations of the actual HIFU treatment, thereby assessing
the feasibility of the treatment. If the simulations indicate that treatment is
feasible, the MR-HIFU procedure will be performed during the second visit.
Blood samples will be obtained before and after the MR-HIFU procedure and
before surgical resection of the tumor to monitor liver function tests (LFTs)
and for future tests. After the MR-HIFU procedure, the patients will stay for
observation in the hospital for up to one night. Approximately one to four
weeks after the MR-HIFU treatment, the patient will undergo surgical resection
of the metastatic liver tumor (standard clinical care). The coagulated tumor
volume in the resection specimen will be compared to the MR imaging data
obtained during the MR-HIFU treatment. Patients will undergo post-operative
follow-up according to standard clinical practice. Patients will be asked about
their experiences and the existence of adverse events in two phone calls, which
take place one week and 30 days after the MR-HIFU procedure. The most important
risks associated with participation in this study include: thermal damage to
the skin or subcutaneous muscle (small risk), damage to other abdominal organs
(very small risk) and complications associated with anesthesia or MRI contrast
agents (very small risk).
Heidelberglaan 100
Utrecht 3584CX
NL
Heidelberglaan 100
Utrecht 3584CX
NL
Listed location countries
Age
Inclusion criteria
- At least 18 years old;
- Able to give informed consent;
- One or more metastatic liver tumor(s);
- Target tumor is eligible for surgical resection;
- Sufficient physical condition to undergo general anesthesia or deep sedation;
- Waist circumference that allows positioning on the HIFU table-top inside the MR bore;
- Based on a clinically available CT/MRI scan, the liver tumor is potentially accessible for MR-HIFU treatment (this relies on the judgment of the investigator and physicians).
Exclusion criteria
- Contra-indication for MRI scanning according to the hospital guidelines;
- Contra-indication to injection of gadolinium-based contrast agent, including known prior allergic reaction to any contrast-agent, and renal failure (defined as GFR < 30mL/min/1.73m2);
- Patients who prefer not to be informed about unexpected MRI findings;
- Surgical clips or considerable scar tissue in the HIFU beam path;
- Past or future other loco regional therapies for the same tumor (that is to be treated with MR-HIFU ablation) until the moment of surgical resection, such as (but not restricted to) RF ablation, microwave ablation, cryoablation, chemo-embolization, radio-embolization, or radiotherapy.
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
In other registers
| Register | ID |
|---|---|
| CCMO | NL45332.041.13 |
| OMON | NL-OMON25843 |