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Kidney CancerPhase 2NCT02828709

Safety and Feasibility of IRE for SRMs

A Phase 2 study testing Irreversible Electroporation in people with Kidney Cancer, run by Dr. Prof. M.P. Laguna Pes at 1 site in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Irreversible Electroporation (IRE) is an emerging technique delivering electrical pulses to ablate tissue, with the theoretical advantage to overcome the main shortcomings of conventional thermal ablation. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Kidney Cancer
What is being tested?
Irreversible Electroporation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteNetherlands
Study dates
Jul 2016to Jul 2019
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years
  • Solid, enhancing mass on cross sectional imaging
  • Signed informed consent
  • Candidate for focal ablative therapy

Who cannot join

  • Irreversible bleeding disorders
  • Inability/unwillingness to interrupt anticoagulation therapy
  • Previous cryoablation, RFA or partial nephrectomy in affected kidney
  • Anaesthesia Surgical Assignment (ASA), category ≤ IV
  • ICD / pacemaker

Trial locations and contacts

1 site in 1 country.

Mara Buijs, MD contact

+31(0)205665793

m.buijs@amc.uva.nl

Maria Pilar Laguna Pes, MD, PhD contact

+31(0)205666928

m.p.lagunapes@amc.uva.nl

Netherlands1 site, 1 recruiting

  • Academic Medical Center (AMC)

    Amsterdam, North Holland, 1105AZ

    Mara Buijs, MD, +31(0)20-5665793, m.buijs@amc.uva.nl

    Recruiting

Other trials in Netherlands

About this study

Official title: The Safety and Feasibility of Irreversible Electroporation for the Ablation of Small Renal Masses

Irreversible Electroporation (IRE) is an emerging technique delivering electrical pulses to ablate tissue, with the theoretical advantage to overcome the main shortcomings of conventional thermal ablation. Recent short-term research showed that IRE for the ablation of renal masses is a safe and feasible treatment option. In an ablate and resect design, histopathological analysis 4 weeks after radical nephrectomy demonstrated that IRE targeted renal tumors were completely covered by ablation zone. In order to develop a validated long-term IRE follow-up study, it is essential to obtain clinical confirmation of the efficacy of this novel technology. Additionally, follow-up after IRE ablation obliges verification of a suitable imaging modality. The objectives of this study are the clinical efficacy and safety of IRE ablation of renal masses and to evaluate the use of cross-sectional imaging modalities in the follow-up after IRE in renal tumours.

This is a prospective, human, in-vivo study among 20 patients presenting with solid enhancing SRM on cross sectional imaging suspect for renal cell carcinoma (RCC). Preoperatively, imaging is required through Magnetic Resonance Imaging (MRI), Contrast-enhanced ultrasound (CEUS) and contrast-enhanced Computed Tomography (CT). Furthermore, serum creatinine levels and VAS scores are obtained. A biopsy of the SRM will be performed in preoperative setting. IRE ablation will be performed using CT-guidance and ablation success will be measured directly after the ablation through contrast-enhanced CT. Device related adverse events (AE) will be registered using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 guideline. One week post ablation only CEUS and MRI will be performed to limit exposure to ionizing radiation. At 3 months, 6 months and 12 months post ablation CEUS, MRI and CT will be performed. Additionally, at these time points serum creatinine levels and VAS scores will be obtained, and quality of life will be assessed through SF-36 questionnaires. Residual and recurrent disease will be assessed through tissue enhancement on cross sectional imaging.

Conditions
Kidney Cancer
Being tested
Irreversible Electroporation
Medical subject headings
Kidney Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Irreversible ElectroporationDevice

    Also called Nanoknife

    Guided by CT and accompanied by an external spacer for fixation, needle electrodes will be placed. The amount of probes and probe placement will be attuned for specific tumour size and location, granting 15mm between the electrodes with an active tip length of 15mm. IRE pulses with pulse intensity of 1500 V/cm will be delivered in 90 consecutive pulses of 90µs.

Study groups in NCT02828709
Study groupRoleWhat they receive
Irreversible electroporation (IRE)ExperimentalIRE is based on high current electric pulses, transferred between two or more placed needle electrodes. Charging the cell membrane causes holes in the cell membrane called "nanopores", resulting in increased permeability of the cell and subsequent cell death.
Receives: Device: Irreversible Electroporation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. safety IRE ablation procedure (evaluating device and procedural adverse events using CTCAE v4.0)

    To determine the safety and feasibility of IRE ablation of small renal masses (≤ 4cm), by evaluating device and procedural adverse events using CTCAE v4.0

    Measured: 2 years

Secondary outcomes (6)

  1. Clinical efficacy ((non-)presence of tumour enhancement on cross-sectional imaging post IRE)

    To determine the clinical efficacy of IRE ablation of small renal masses (≤ 4cm), assessed by calculating recurrence and residual disease at follow-up, measured through the (non-)presence of tumour enhancement on cross-sectional imaging post IRE

    Measured: 2 years

  2. Cross sectional imaging post ablation

    To evaluate the use of CT, MRI, and CEUS in the imaging of ablation success, extend of the ablation zone, 1 week, 3 months, 6 months, and 1 year post IRE

    Measured: 2 years

  3. Renal function

    To evaluate the effect of RE ablation of small renal masses (≤ 4cm) on the renal function, measured by serum creatinine levels and estimated Glomerular Filtration Rate (eGFR)

    Measured: 2 years

  4. Average length of hospital stay

    To evaluate the effect of IRE ablation of small renal masses (≤ 4cm) on the length of hospital stay, measured in average stay in days

    Measured: 2 years

  5. Quality of Life

    To evaluate the effect of IRE ablation of small renal masses (≤ 4cm) on the quality of life, assessed through SF-36 questionnaires

    Measured: 2 years

  6. Postoperative pain score

    To asses the effect of IRE ablation of small renal masses (≤ 4cm), assessed through VAS score and analgesics use

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2016 (estimated)
  2. Study startJul 2016
  3. Primary completionJul 2018 (estimated)
  4. Study completionJul 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02828709
Sponsor's protocol ID
NL5693501816
Status last verified
Sep 2016
First submitted
4 Jul 2016
Last updated
27 Sep 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Thomson KR, Cheung W, Ellis SJ, Federman D, Kavnoudias H, Loader-Oliver D, Roberts S, Evans P, Ball C, Haydon A. Investigation of the safety of irreversible electroporation in humans. J Vasc Interv Radiol. 2011 May;22(5):611-21. doi: 10.1016/j.jvir.2010.12.014. Epub 2011 Mar 25.

    PubMed 21439847

  • Wendler JJ, Ricke J, Pech M, Fischbach F, Jurgens J, Siedentopf S, Roessner A, Porsch M, Baumunk D, Schostak M, Kollermann J, Liehr UB. First Delayed Resection Findings After Irreversible Electroporation (IRE) of Human Localised Renal Cell Carcinoma (RCC) in the IRENE Pilot Phase 2a Trial. Cardiovasc Intervent Radiol. 2016 Feb;39(2):239-50. doi: 10.1007/s00270-015-1200-6. Epub 2015 Sep 4.

    PubMed 26341653

  • Trimmer CK, Khosla A, Morgan M, Stephenson SL, Ozayar A, Cadeddu JA. Minimally Invasive Percutaneous Treatment of Small Renal Tumors with Irreversible Electroporation: A Single-Center Experience. J Vasc Interv Radiol. 2015 Oct;26(10):1465-71. doi: 10.1016/j.jvir.2015.06.028. Epub 2015 Aug 4.

    PubMed 26250855

  • Pech M, Janitzky A, Wendler JJ, Strang C, Blaschke S, Dudeck O, Ricke J, Liehr UB. Irreversible electroporation of renal cell carcinoma: a first-in-man phase I clinical study. Cardiovasc Intervent Radiol. 2011 Feb;34(1):132-8. doi: 10.1007/s00270-010-9964-1. Epub 2010 Aug 15.

    PubMed 20711837

  • van den Bos W, de Bruin DM, van Randen A, Engelbrecht MR, Postema AW, Muller BG, Varkarakis IM, Skolarikos A, Savci-Heijink CD, Jurhill RR, Zondervan PJ, Laguna Pes MP, Wijkstra H, de Reijke TM, de la Rosette JJ. MRI and contrast-enhanced ultrasound imaging for evaluation of focal irreversible electroporation treatment: results from a phase I-II study in patients undergoing IRE followed by radical prostatectomy. Eur Radiol. 2016 Jul;26(7):2252-60. doi: 10.1007/s00330-015-4042-3. Epub 2015 Oct 8.

    PubMed 26449559

  • van den Bos W, Scheffer HJ, Vogel JA, Wagstaff PG, de Bruin DM, de Jong MC, van Gemert MJ, de la Rosette JJ, Meijerink MR, Klaessens JH, Verdaasdonk RM. Thermal Energy during Irreversible Electroporation and the Influence of Different Ablation Parameters. J Vasc Interv Radiol. 2016 Mar;27(3):433-43. doi: 10.1016/j.jvir.2015.10.020. Epub 2015 Dec 17.

    PubMed 26703782

  • Wagstaff PG, de Bruin DM, van den Bos W, Ingels A, van Gemert MJ, Zondervan PJ, Verdaasdonk RM, van Lienden KP, van Leeuwen TG, de la Rosette JJ, Laguna Pes MP. Irreversible electroporation of the porcine kidney: Temperature development and distribution. Urol Oncol. 2015 Apr;33(4):168.e1-7. doi: 10.1016/j.urolonc.2014.11.019. Epub 2014 Dec 31.

    PubMed 25557146

  • Buijs M, van Lienden KP, Wagstaff PG, Scheltema MJ, de Bruin DM, Zondervan PJ, van Delden OM, van Leeuwen TG, de la Rosette JJ, Laguna MP. Irreversible Electroporation for the Ablation of Renal Cell Carcinoma: A Prospective, Human, In Vivo Study Protocol (IDEAL Phase 2b). JMIR Res Protoc. 2017 Feb 16;6(2):e21. doi: 10.2196/resprot.6725.

    PubMed 28209559

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Irreversible Electroporation in people with Kidney Cancer, run by Dr. Prof. M.P. Laguna Pes at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Mara Buijs, MD (+31(0)205665793, m.buijs@amc.uva.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

safety IRE ablation procedure (evaluating device and procedural adverse events using CTCAE v4.0) (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02828709, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2016.

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