Condition category
Cancer
Date applied
13/04/2015
Date assigned
14/06/2015
Last edited
08/06/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Radiofrequency ablation is a cancer treatment that uses heat made by radio waves to kill cancer cells. Radiofrequency is a type of electrical energy that heats up solid tumours and kills it. The aim of this study is to compare a new method we have developed for ablating liver tumours, the hepatic "cool-wet" radiofrequency ablation system with other methods already available. We are also going to investigate how safe the method is to use (phase 1 of the study) and how effective a treatment it is (phase 2).

Who can participate?
Adults (aged at least 18) with liver cancer.

What does the study involve?
There are two phases to the study. N phase 1, the safety of “cool-wet” radiofrequency system is tested. In phase 2, participants are randomly allocated into one of two groups. Those in group 1 undergo a conventional hepatic (liver) ablation technique. Those in group 2 are given the new “cool-wet” hepatic radiofrequency ablation system. The clinical outcomes of the two groups of participants are then compared in terms of whether the treated cancer reoccurred.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
The Hospital del Mar (Spain)

When is the study starting and how long is it expected to run for?
January 2012 to December 2017

Who is funding the study?
Health Research Fund (Fondo de Investigación Sanitaria)(Spain)

Who is the main contact?
Dr Rita Quesada

Trial website

Contact information

Type

Public

Primary contact

Dr Rita Quesada

ORCID ID

Contact details

Parc de Rerceca Biomèdica de Barcelona
Doctor Aiguader
88
08003 Barcelona
Barcelona
08003
Spain

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

438/13/EC

Study information

Scientific title

Treatment of primary and secondary liver tumors with an hepatic ablation cool-wet radiofrequency system: an interventional single-centre study.

Acronym

GNOMON

Study hypothesis

1. Assess the safety of the radio-frequency ablation with the new device ("cool-wet system" to treat hepatocellular carcinoma and liver metastases between 1.5 - 4 cm of diameter.
2. Verify if the new radio-frequency method is at least as effective than the conventional method in terms of lower recurrence and total ablation of the lesion (single puncture). The conventional method considers the current technique performed by interventional radiologists and surgeons of the hospital (ablation method cool-tip and microwaves) for any of the possible ways of application (percutaneous, laparoscopic or open surgery).

Ethics approval

1. Ethical Committee of Clinical Research of the Hospital del Mar, 27/06/2012, ref: 2012/4776/I
2. Agencia Española del Medicamento y Producto Sanitario, 10/06/2013, ref: 438/13/EC

Study design

Interventional single-centre study.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Hepatocellular carcinoma and liver metastases between 1.5 - 4 cm of diameter.

Intervention

Radio-frequency ablation with a "Cool-wet" radio-frequency system
1. Phase I: Safety pilot study based on 20 patients. There is no control group
2. Phase II: Randomized, parallel -group single-blind study
2.1. Group 1: Conventional hepatic ablation technique (control group). The method of ablation control is based on microwaves (AMICA). It considers 55 patients
2.2. Group 2: New "cool-wet" hepatic radio-frequency ablation system previously described in Phase I. 55 patients

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

1. HLR (Hepatic local recurrence): Characterized by a partial response (PR) or disease progression (DP) of the treated target lesion according to RECIST 1.1 VA. in the abdominal CT or MRI at 6 months (maximum tolerance 50 days) and then every 6 months until 5 years. The maximum cutting thickness to evaluated this is 5 mm.
2. MDA (Minimum Diamater Ablation): Defined as the smallest diameter of a single ablation measured by an abdominal CT or MRI at 6-months of the procedure. When they have been treated more than one target lesion, the smallest diameter will be considered.

Secondary outcome measures

1. Maximum diameter of the ablation (anteroposterior, transverse and craniocaudal).
2. Mean volume of the ablation. Measured by digital reconstruction from CT or MRI after a month of PO using appropriate image software.

Overall trial start date

01/01/2012

Overall trial end date

01/12/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Nodules suggestive of HCC or liver metastases from any source as abdominal CT, MRI or biopsy. The initial imaging test (CT or MRI) must not be older than 30 days (50 days maximum tolerance).
2. Considered unresectable hepatic nodules in multidisciplinary and capable local treatment session
3. Number of nodes: between 1 and 3
4. Size of the nodules: between 1.5 and 4 cm
5. Percutaneous, laparoscopic or open surgical access.
6. Signature of informed consent
7. Aged at least 18

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

130

Participant exclusion criteria

1. Higher than third level of Anesthetic risk measured by the classification of the American Association anesthesia (ASA IV)
2. Carrier of a cardiac pacemaker
3. Thrombocytopenia <50,000 / mL
4. Suspicion of thrombosis portal by presence of tumor
5. Child C and grading of hepatic failure
6. Previous biliodigestive anatomosis
7. Hepatic subcapsular nodule

Recruitment start date

01/01/2013

Recruitment end date

01/12/2015

Locations

Countries of recruitment

Spain

Trial participating centre

Hospital del Mar
Spain

Sponsor information

Organisation

Parc de Salut Mar- Hospital del Mar

Sponsor details

Passeig Marítim 25-29
Barcelona
08003
Spain

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Charity

Funder name

Health Research Fund (Fondo de Investigación Sanitaria) (FIS PI12/00799)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We are interested in publishing at least two papers, one after the first Phase I and another after Phase II. We have already finished the first Phase of the study and we are currently analyzing the results. We plan to publish these as soon as we have them. The second publication will depend on the inclusion of patients.

Intention to publish date

Participant level data

Other

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes