Secondary Malignant Neoplasm of LiverNCT01457599
Computertomography-guided Wire Marking of the Liver
An observational study of Secondary Malignant Neoplasm of Liver, run by Medical University of Graz at 1 site in Austria.
Trial summary
The aim of the study is to evaluate if it is possible to mark with a wire colorectal hepatic metastases after complete response to a neoadjuvant chemotherapy.Primary the investigators want to investigate if the wire marking is a possibility to mark respectively to identify these lesions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Secondary Malignant Neoplasm of Liver
- What is being tested?
- Computertomography-guided marking of colorectal liver metastases
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteAustria
- Study dates
- Jul 2011to Aug 2016
- Phase
- Observational
- 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
Study population: Tertiary care clinic
Who may be able to join
- Histologic verified cancer of the colon and rectum with metastases into the liver
- Neoadjuvant chemotherapy with complete radiologic response of metastases in apparative diagnostic respectively metastases with a diameter ≤ 1 cm.
- Technically Resectability
- Age ≥ 18 Years
- Written informed consent
Who cannot join
- Age < 18 Years
- Technically Irresectability
- Neoadjuvant chemotherapy and response of metastases, however with a diameter > 1 cm.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Computertomography-guided Wire Marking of Colorectal Hepatic Metastases After Complete Response to Neoadjuvant Chemotherapy. A Pilot Study
The aim of the study is to evaluate if it is possible to mark with a wire colorectal hepatic metastases after complete response to a neoadjuvant chemotherapy.Primary the investigators want to investigate if the wire marking is a possibility to mark respectively to identify these lesions. Further the investigators want to evaluate how many patients with complete radiologic have complete histologic response in their specimen respectively in how many specimens in the definitive histology tumor cells are visible.
Read the detailed description
Colorectal Cancer is most common in western countries. In 2007 in Austria 4462 new colorectal cancers were diagnosed. The most common place of metastasis is the liver. Approximately 15% of patients have metastasis at time of diagnosis of primary tumor and further 50% will develop metastases in the further course of the disease.However only 10-25% of patients are candidates for liver resection. New chemotherapeutics, new targeted therapies with monoclonal antibodies and better surgical techniques improved response rates, resection rates and overall survival. Owing to improved response rates metastases in the liver partially respectively completely disappeared, so that these lesions are not more visible in apparative diagnostic like CT-scan and MRI.
The question is now what to do with this patients? In the literature there is no evidence how to manage these patients. Conservative management would lead to a reoccurrence of metastases in the liver. On the other side surgical management is difficult, because metastases are preoperatively and intraoperatively not visible and resection is only possible with the removement of greater amounts of healthy tissue.
The computer tomography-guided wire marking of the metastases in the liver is a possibility to overcome these problems. All patients with complete radiologic response of metastases in the liver and metastases ≤ 1 cm are included in the study (RECISTE-Criteria). On day of surgical procedure patients will brought to interventional radiologist and based on computer tomography images before neoadjuvant chemotherapy the lesions will be marked computer tomography-guided with a wire(X-Reidy Breast Lesion Localization Needle, Cook Medical). The wire is placed percutaneously and under antibiotic prophylaxis. After the marking procedure, the patient is brought into the operating room to resect the metastases in the liver.
- Conditions
- Secondary Malignant Neoplasm of Liver
- Being tested
- Computertomography-guided marking of colorectal liver metastases
- Keywords
- liver-colorectal metastases-computertomography-guided-wire-chemotherapy-complete response, Feasibility, safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computertomography-guided marking of colorectal liver metastasesProcedure or surgery
Computertomography-guided marking of colorectal liver metastases
| Study group | Role | What they receive |
|---|---|---|
| Marking Liver | Not described Receives: Procedure: Computertomography-guided marking of colorectal liver metastases |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
Sensitivity of wire marking to find liver metastases with complete response to neoadjuvant chemotherapy
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2011 (estimated)
- Study startJul 2011
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Secondary Malignant Neoplasm of LiverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kornprat Peter, MD, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01457599
- Sponsor's protocol ID
- INS-621000-0274-002
- Status last verified
- Aug 2016
- First submitted
- 18 Oct 2011
- Last updated
- 16 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computertomography-guided Wire Marking of Colorectal Hepatic Metastases After Complete Response to Neoadjuvant Chemotherapy. A Pilot Study
- ClinicalTrials.gov ID
- NCT01457599
- Acronym / sponsor ID
- INS-621000-0274-002
- Conditions
- Secondary Malignant Neoplasm of Liver
- Keywords
- liver-colorectal metastases-computertomography-guided-wire-chemotherapy-complete response, Feasibility, safety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 24 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to evaluate if it is possible to mark with a wire colorectal hepatic metastases after complete response to a neoadjuvant chemotherapy.Primary the investigators want to investigate if the wire marking is a possibility to mark respectively to identify these lesions. Further the investigators want to evaluate how many patients with complete radiologic have complete histologic response in their specimen respectively in how many specimens in the definitive histology tumor cells are visible.
Detailed description
Colorectal Cancer is most common in western countries. In 2007 in Austria 4462 new colorectal cancers were diagnosed. The most common place of metastasis is the liver. Approximately 15% of patients have metastasis at time of diagnosis of primary tumor and further 50% will develop metastases in the further course of the disease.However only 10-25% of patients are candidates for liver resection. New chemotherapeutics, new targeted therapies with monoclonal antibodies and better surgical techniques improved response rates, resection rates and overall survival. Owing to improved response rates metastases in the liver partially respectively completely disappeared, so that these lesions are not more visible in apparative diagnostic like CT-scan and MRI.
The question is now what to do with this patients? In the literature there is no evidence how to manage these patients. Conservative management would lead to a reoccurrence of metastases in the liver. On the other side surgical management is difficult, because metastases are preoperatively and intraoperatively not visible and resection is only possible with the removement of greater amounts of healthy tissue.
The computer tomography-guided wire marking of the metastases in the liver is a possibility to overcome these problems. All patients with complete radiologic response of metastases in the liver and metastases ≤ 1 cm are included in the study (RECISTE-Criteria). On day of surgical procedure patients will brought to interventional radiologist and based on computer tomography images before neoadjuvant chemotherapy the lesions will be marked computer tomography-guided with a wire(X-Reidy Breast Lesion Localization Needle, Cook Medical). The wire is placed percutaneously and under antibiotic prophylaxis. After the marking procedure, the patient is brought into the operating room to resect the metastases in the liver.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Marking Liver | – | Procedure: Computertomography-guided marking of colorectal liver metastases |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Tertiary care clinic
Key inclusion criteria (5 listed)
- Histologic verified cancer of the colon and rectum with metastases into the liver
- Neoadjuvant chemotherapy with complete radiologic response of metastases in apparative diagnostic respectively metastases with a diameter ≤ 1 cm.
- Technically Resectability
- Age ≥ 18 Years
- Written informed consent
Key exclusion criteria (3 listed)
- Age < 18 Years
- Technically Irresectability
- Neoadjuvant chemotherapy and response of metastases, however with a diameter > 1 cm.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computertomography-guided marking of colorectal liver metastasesComputertomography-guided marking of colorectal liver metastases | Procedure or surgery | Marking Liver |
Primary outcome
Sensitivity
Time frame: One Year
Sensitivity of wire marking to find liver metastases with complete response to neoadjuvant chemotherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2016.
- Individual participant dataSharing planned: Undecided
Related trials for Secondary Malignant Neoplasm of Liver
RecruitingObservational study
Cancer Experience Registry (CER) for Cancer Patients and Caregivers
Neoplasms, Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Not yet recruitingObservational study
Immune-Related Adverse Events and Clinical Outcomes of First-Line Immunotherapy in Egyptian Patients With Unresectable Hepatocellular Carcinoma
Hepatocellular Carcinoma, Hepatocellular Carcinoma (HCC)
Not yet recruitingObservational study
A Retrospective Registry of Intelliblate DUAL Channel Microwave Ablation
Liver Ablation, Liver Cancer
RecruitingPhase 2
SBRT of Metastases Following Neo-adjuvant Treatment for Colorectal Cancer With Synchronous Liver Metastases
Colorectal Cancer, Liver Metastasis Colon Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Secondary Malignant Neoplasm of Liver, run by Medical University of Graz at 1 site in Austria.
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 5 inclusion and 3 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: finished, as of the sponsor's last update on 16 Aug 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 Austria. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (time frame: One Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Aug 2016.