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Liver CancerPhase 2NCT00019604

Radiofrequency Ablation in Treating Patients With Unresectable Primary or Metastatic Liver Cancer

A Phase 2 study testing computed tomography, magnetic resonance imaging and positron emission tomography in people with Liver Cancer and Metastatic Cancer, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

RATIONALE: Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells. PURPOSE: Phase II trial to study the effectiveness of radiofrequency ablation in treating patients who have unresectable primary or metastatic liver cancer. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
computed tomography, magnetic resonance imaging and positron emission tomography
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteUnited States
Study dates
Aug 1998to Jan 2009
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed primary or metastatic liver lesions
  • Not a candidate for surgical resection
  • Must have six or fewer lesions and no single lesion greater than 7 cm in diameter
  • Extrahepatic disease allowed

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Eastern Cooperative Oncology Group (ECOG) 0-2

Life expectancy:

  • At least 3 months

Hematopoietic:

  • Platelet count at least 50,000/mm^3
  • Prothrombin time (PT) or partial thromboplastin time (PTT) no greater than 1.5 times control (except for therapeutically anticoagulated nonrelated medical conditions [e.g., atrial fibrillation])

Hepatic:

  • Bilirubin no greater than 3.0 mg/dL

Renal:

  • Creatinine no greater than 2.5 mg/dL

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • No pacemakers, cerebral aneurysm clips, shrapnel injury, or implantable electronic devices
  • No known uncontrollable serious reactions (e.g., anaphylaxis) to contrast agents used in this study
  • Weight less than 136 kg

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • Not specified

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Not specified

Surgery:

  • Not specified

Other:

  • Concurrent systemic therapy for extrahepatic disease is allowed only if begun prior to radiofrequency ablation

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

    Bethesda, Maryland, 20892-1182

Other trials in United States

About this study

Official title: The Use of Radiofrequency Ablation to Treat Hepatic Neoplasms

RATIONALE: Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.

PURPOSE: Phase II trial to study the effectiveness of radiofrequency ablation in treating patients who have unresectable primary or metastatic liver cancer.

Read the detailed description

OBJECTIVES:

  • Evaluate the nature and duration of response of patients with primary or metastatic liver neoplasms, who are not candidates for surgical resection, treated with radiofrequency interstitial tissue ablation.
  • Evaluate the ability of dynamic magnetic resonance imaging (MRI) to assess the effects of this therapy on tumor blood flow and tumor vascular density in these patients.
  • Determine the ability of positron emission tomography with fludeoxyglucose F 18 (FDG-PET) to monitor response after treatment with this therapy in these patients.
  • Compare FDG-PET results with computed tomography (CT) scan, biopsy, and serum marker results in patients treated with this therapy.
  • Compare the performance of FDG-PET with CT scan and MRI, in terms of their ability to assess the efficacy of this therapy in these patients.

OUTLINE: Lesions are targeted by ultrasound and then radiofrequency ablation needles are inserted into the lesions and heated to a target temperature greater than 60 degrees C for 15 minutes, though exposure time may vary depending on temperatures achieved. To achieve a 1 cm margin of ablated tissue around each lesion, multiple ablation courses may be performed, depending on the size of the lesions and the time required to complete the treatment.

Patients undergo magnetic resonance imaging with gadopentetate dimeglumine contrast, CT scan, ultrasound, and positron emission tomography with fludeoxyglucose F 18 at baseline, 6 weeks, every 3 months for 1 year, and then every 6 months for 2 years.

Patients are followed at 6 weeks, every 3 months for 1 year, and then every 6 months for 2 years or until evidence of recurrence.

PROJECTED ACCRUAL: A total of 58 patients will be accrued for this study within 6 years.

Being tested
computed tomography, magnetic resonance imaging, positron emission tomography, radiofrequency ablation, radionuclide imaging
Keywords
localized unresectable adult primary liver cancer, recurrent adult primary liver cancer, liver metastases, unspecified adult solid tumor, protocol specific
Medical subject headings
Liver Neoplasms, Neoplasm Metastasis, Carcinoma, Hepatocellular

What participants receive

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

  • computed tomographyProcedure or surgery

    Scan to assess the effects of ablation.

  • magnetic resonance imagingProcedure or surgery

    Imaging used to assess the effects of this ablative therapy on tumor vascular density.

  • positron emission tomographyProcedure or surgery

    Physiology based method of imaging disease based on uptake and metabolism of radiopharmaceutical by the tissues.

  • radiofrequency ablationProcedure or surgery

    Radiofrequency ablation uses saline infusion into and out of needle/electrode through a closed system. More energy may be deposited without tissue-charring or gas vaporization.

  • radionuclide imagingProcedure or surgery

    Imaging following injection of a radioactive material.

  • ultrasound imagingProcedure or surgery

    An ultrasound (e.g. sound waves) is used to identify the lesion and needle placement.

  • fludeoxyglucose F 18 (FDG-PET)Radiation

    FDG PET scans rely on metabolic changes to evaluate response to therapy.

  • gadopentetate dimeglumineRadiation

    Food and Drug Administration approved contrast agent.

Study groups in NCT00019604
Study groupRoleWhat they receive
Radiofrequency ablation in liver cancerExperimentalThis trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
Receives: Procedure: computed tomography; Procedure: magnetic resonance imaging; Procedure: positron emission tomography; Procedure: radiofrequency ablation; Procedure: radionuclide imaging; Procedure: ultrasound imaging; Radiation: fludeoxyglucose F 18 (FDG-PET); Radiation: gadopentetate dimeglumine

What is being measured

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

  1. Response

    Standard response criteria will be used to assess the CT (computed tomography) scan images on a lesion per lesion basis. Complete response is complete disappearance of the index lesion on followup scan when compared to the pretreatment images. Partial response is a decrease of 50% or greater in the product of the perpendicular diameters of the measured lesion following treatment compared to the pretreatment images. Minor response is a decrease between 25% and 49% in the product of the perpendicular diameters of the measured lesion following treatment compared to the pretreatment images. Stable disease is no change in the size of the treated lesion. Progressive disease is an increase of greater than 25% in the product of the perpendicular diameters of the measured lesion following treatment compared to the pretreatment images.

Secondary outcomes (9)

  1. Number of Participants With Adverse Events

    Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.

    Measured: 9 years, 9 months

  2. Tumor Blood Flow

    Tumor blood flow was to be assessed by magnetic resonance imaging (MRI) and compared to data collected on baseline pretreatment images and other appropriate time points for changes in tumor microvascular density.

    Measured: Baseline, 3 months, and 6 months following treatment

  3. Tumor Vascular Density

    Tumor vascular density was to be assessed by magnetic resonance imaging (MRI) and compared to data collected on baseline pretreatment images and other appropriate time points for changes in tumor microvascular density. Patterns of MRI contrast uptake within tumors correlate with microvessel density.

    Measured: Baseline, 3 months, and 6 months following treatment

  4. Percentage of Participants With a Response Using Fludeoxyglucose (18F) - Positron Emission Tomography (FDG-PET) Following Radiofrequency Ablation (RFA)

    Response was to be evaluated by the standard response criteria. Complete response is the complete disappearance of the index lesion on follow-up scan when compared to the pretreatment images. Partial response is a decrease of 50% or greater in the product of the perpendicular diameters of the measured lesion following treatment compared to the pretreatment images. Minor response is a decrease between 25% and 49% in the product of the perpendicular diameters of the measured lesion following treatment compared to the pretreatment images. Stable disease is no change in the size of the treated lesion. Progressive disease is an increase of greater than 25% in the product of the perpendicular diameters of the measured lesion following treatment compared to the pretreatment images.

    Measured: Baseline, 6 weeks, 3 months, and 6 months following treatment

  5. Compare Fludeoxyglucose (18F) Positron-Emission Tomography (FDG-PET) Results With Computed Tomography (CT)

    Participants were to undergo FDG-PET scanning and CT scans to compare changes in size of metabolically active volume and standard uptake value (tumor metabolism).

    Measured: Baseline, 6 weeks, 3 months, and 6 months following treatment

  6. Compare Fludeoxyglucose (18F) Positron-Emission Tomography (FDG-PET) Results With Biopsies

    Participants were to undergo tissue biopsies of tumor to quantify changes in the tumor to see if the changes we see on the imaging studies are the same as the changes in the tumor.

    Measured: Baseline, 6 weeks, 3 months, and 6 months following treatment

  7. Compare Fludeoxyglucose (18F) Positron-Emission Tomography (FDG-PET) Results With Serum Markers

    Images obtained by the FDG-PET was to be processed for changes in measured parameters and quantified compared to serum markers at baseline and appropriate follow-up points.

    Measured: Baseline, 6 weeks, 3 months, and 6 months following treatment

  8. Compare the Performance of Fludeoxyglucose (18F) Positron-Emission Tomography to Computed Tomography and Magnetic Resonance Imaging With Respect to Their Ability to Assess the Effects of Radiofrequency Ablation on the Treatment of Hepatic Neoplasms

    Images obtained by the FDG-PET, MRI and CT was to be processed for changes in measured parameters and quantified compared to baseline (e.g., <median change, >median change in size on CT, computed by subtracting the baseline value from the value at the appropriate follow-up point).

    Measured: Baseline, 6 weeks, 3 months, and 6 months following treatment

  9. Evaluate the Ability of Fludeoxyglucose (18F) Positron-Emission Tomography (FDG-PET) to Monitor Response Following Radiofrequency Ablation (RFA)

    PET scan images was to be read by a physician experienced in the interpretation of whole body PET imaging. The region of interest was to be performed in any abnormal sites of uptake that is a candidate and or has been RFA ablated.

    Measured: Baseline, 6 weeks, 3 months, and 6 months following treatment

Timeline

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

  1. First posted27 Jan 2003 (estimated)
  2. Study startAug 1998
  3. Primary completionJan 2009
  4. Study completionJan 2009

Why it stopped: Principal investigator left the institution.

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
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00019604
Sponsor's protocol ID
990025
Other IDs
99-C-0025, CDR0000066875
Status last verified
Dec 2016
First submitted
11 Jul 2001
Last updated
3 Feb 2017
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing computed tomography, magnetic resonance imaging and positron emission tomography in people with Liver Cancer and Metastatic Cancer, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.

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

Who may be eligible to take part?

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: stopped early, as of the sponsor's last update on 3 Feb 2017. 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 United States. 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?

Yes. Results are posted in the registry (first posted 12 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Response. 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 NCT00019604.

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 3 Feb 2017.

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