Radiofrequency Ablation in Treating Patients With Unresectable Primary or Metastatic Liver Cancer
7. december 2016 opdateret af: Caryn Steakley, R.N., National Institutes of Health Clinical Center (CC)
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.
Studieoversigt
Status
Afsluttet
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
44
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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Maryland
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Bethesda, Maryland, Forenede Stater, 20892-1182
- Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Radiofrequency ablation in liver cancer
This 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.
|
Scan to assess the effects of ablation.
Imaging used to assess the effects of this ablative therapy on tumor vascular density.
Physiology based method of imaging disease based on uptake and metabolism of radiopharmaceutical by the tissues.
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.
Imaging following injection of a radioactive material.
An ultrasound (e.g.
sound waves) is used to identify the lesion and needle placement.
FDG PET scans rely on metabolic changes to evaluate response to therapy.
Food and Drug Administration approved contrast agent.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
|---|---|
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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.
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Number of Participants With Adverse Events
Tidsramme: 9 years, 9 months
|
Here is the number of participants with adverse events.
For a detailed list of adverse events see the adverse event module.
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9 years, 9 months
|
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Tumor Blood Flow
Tidsramme: Baseline, 3 months, and 6 months following treatment
|
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.
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Baseline, 3 months, and 6 months following treatment
|
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Tumor Vascular Density
Tidsramme: Baseline, 3 months, and 6 months following treatment
|
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.
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Baseline, 3 months, and 6 months following treatment
|
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Percentage of Participants With a Response Using Fludeoxyglucose (18F) - Positron Emission Tomography (FDG-PET) Following Radiofrequency Ablation (RFA)
Tidsramme: Baseline, 6 weeks, 3 months, and 6 months following treatment
|
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.
|
Baseline, 6 weeks, 3 months, and 6 months following treatment
|
|
Compare Fludeoxyglucose (18F) Positron-Emission Tomography (FDG-PET) Results With Computed Tomography (CT)
Tidsramme: Baseline, 6 weeks, 3 months, and 6 months following treatment
|
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).
|
Baseline, 6 weeks, 3 months, and 6 months following treatment
|
|
Compare Fludeoxyglucose (18F) Positron-Emission Tomography (FDG-PET) Results With Biopsies
Tidsramme: Baseline, 6 weeks, 3 months, and 6 months following treatment
|
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.
|
Baseline, 6 weeks, 3 months, and 6 months following treatment
|
|
Compare Fludeoxyglucose (18F) Positron-Emission Tomography (FDG-PET) Results With Serum Markers
Tidsramme: Baseline, 6 weeks, 3 months, and 6 months following treatment
|
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.
|
Baseline, 6 weeks, 3 months, and 6 months following treatment
|
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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
Tidsramme: Baseline, 6 weeks, 3 months, and 6 months following treatment
|
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).
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Baseline, 6 weeks, 3 months, and 6 months following treatment
|
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Evaluate the Ability of Fludeoxyglucose (18F) Positron-Emission Tomography (FDG-PET) to Monitor Response Following Radiofrequency Ablation (RFA)
Tidsramme: Baseline, 6 weeks, 3 months, and 6 months following treatment
|
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.
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Baseline, 6 weeks, 3 months, and 6 months following treatment
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Steven A Libutti, MD, National Cancer Institute, National Institutes of Health
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. august 1998
Primær færdiggørelse (Faktiske)
1. januar 2009
Studieafslutning (Faktiske)
1. januar 2009
Datoer for studieregistrering
Først indsendt
11. juli 2001
Først indsendt, der opfyldte QC-kriterier
26. januar 2003
Først opslået (Skøn)
27. januar 2003
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
3. februar 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
7. december 2016
Sidst verificeret
1. december 2016
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 990025
- 99-C-0025
- CDR0000066875
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Ingen
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