Radiofrequency Ablation in Treating Patients With Unresectable Primary or Metastatic Liver Cancer
7. prosince 2016 aktualizováno: 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.
Přehled studie
Postavení
Ukončeno
Podmínky
Detailní popis
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.
Typ studie
Intervenční
Zápis (Aktuální)
44
Fáze
- Fáze 2
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
-
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Maryland
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Bethesda, Maryland, Spojené státy, 20892-1182
- Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
|---|---|
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Response
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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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Number of Participants With Adverse Events
Časové okno: 9 years, 9 months
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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
Časové okno: Baseline, 3 months, and 6 months following treatment
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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
Časové okno: Baseline, 3 months, and 6 months following treatment
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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)
Časové okno: 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.
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Baseline, 6 weeks, 3 months, and 6 months following treatment
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Compare Fludeoxyglucose (18F) Positron-Emission Tomography (FDG-PET) Results With Computed Tomography (CT)
Časové okno: Baseline, 6 weeks, 3 months, and 6 months following treatment
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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).
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Baseline, 6 weeks, 3 months, and 6 months following treatment
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Compare Fludeoxyglucose (18F) Positron-Emission Tomography (FDG-PET) Results With Biopsies
Časové okno: Baseline, 6 weeks, 3 months, and 6 months following treatment
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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.
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Baseline, 6 weeks, 3 months, and 6 months following treatment
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Compare Fludeoxyglucose (18F) Positron-Emission Tomography (FDG-PET) Results With Serum Markers
Časové okno: Baseline, 6 weeks, 3 months, and 6 months following treatment
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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.
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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
Časové okno: Baseline, 6 weeks, 3 months, and 6 months following treatment
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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)
Časové okno: Baseline, 6 weeks, 3 months, and 6 months following treatment
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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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Steven A Libutti, MD, National Cancer Institute, National Institutes of Health
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. srpna 1998
Primární dokončení (Aktuální)
1. ledna 2009
Dokončení studie (Aktuální)
1. ledna 2009
Termíny zápisu do studia
První předloženo
11. července 2001
První předloženo, které splnilo kritéria kontroly kvality
26. ledna 2003
První zveřejněno (Odhad)
27. ledna 2003
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
3. února 2017
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
7. prosince 2016
Naposledy ověřeno
1. prosince 2016
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 990025
- 99-C-0025
- CDR0000066875
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Ne
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