Radiofrequency Ablation in Treating Patients With Unresectable Primary or Metastatic Liver Cancer
2016年12月7日 更新者：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.
調査の概要
状態
終了しました
詳細な説明
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.
研究の種類
介入
入学 (実際)
44
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Maryland
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Bethesda、Maryland、アメリカ、20892-1182
- Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
|---|---|
|
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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Number of Participants With Adverse Events
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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.
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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
時間枠：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)
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Steven A Libutti, MD、National Cancer Institute, National Institutes of Health
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
1998年8月1日
一次修了 (実際)
2009年1月1日
研究の完了 (実際)
2009年1月1日
試験登録日
最初に提出
2001年7月11日
QC基準を満たした最初の提出物
2003年1月26日
最初の投稿 (見積もり)
2003年1月27日
学習記録の更新
投稿された最後の更新 (見積もり)
2017年2月3日
QC基準を満たした最後の更新が送信されました
2016年12月7日
最終確認日
2016年12月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- 990025
- 99-C-0025
- CDR0000066875
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
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