Radiofrequency Ablation of Tumors
Radiofrequency Ablation of Tumors (RFA) A Phase I Study
Background: This prospective study was designed to be the first to evaluate the toxicity of radiofrequency ablation (RFA) in patients with recurrent pediatric solid tumors.
Methods: From 2003 through 2006, we conducted a phase I, IRB-approved study of RFA for recurrent solid tumors. A multidisciplinary cancer management team selected appropriate candidates for the study. Imaging-guided RFA was performed percutaneously. Response was assessed at 3 months. Repeat RFA was performed for some incompletely ablated or new lesions.
調査の概要
研究の種類
入学 (実際)
段階
- フェーズ 1
連絡先と場所
研究場所
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Tennessee
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Memphis、Tennessee、アメリカ、38105
- St. Jude Children's Research Hospital
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
General
- Any age
- Previously diagnosed malignancy (including aggressive fibromatosis) originally acquired during childhood (<21 years-of-age)
- Patients who have undergone previous RFA may be enrolled again (different disease site) or receive subsequent ablation (same disease site) as long as the eligibility criteria are met at the time of re-enrollment, or a second ablation on study.
- The subject is medically appropriate for the study as determined by a consensus of professionals at multidisciplinary tumor conference prior to enrollment. This discussion will be documented in the chart of the potential subject to be recruited for this study.
- Histopathological material is available prior to the RF ablation except in patients with obvious tumor recurrence.
- No Pacemakers or Automatic Implantable Cardioverter/Defibrillators (AICDs)
- No tissue burns anticipated from implanted metal
- Normal renal function (Creatinine < 2mg/dL)
- Absolute neutrophil count (ANC) > 1000/cu.mm.
- No uncorrectable coagulopathy (INR>1.5, PTT and PT > 1.5 x the upper limit of normal)
- No uncorrectable thrombocytopenia (platelet count < 50,000/mm3)
- Life expectancy over 30 days
- RF ablation targets in the liver, lung or musculoskeletal system that meet the following criteria:
Hepatic lesions
- Intrahepatic metastases not amenable to other therapy
- Primary hepatic tumor if RF ablation of a portion of the tumor can lead to primary tumor resection rather than hepatic transplantation
- Single primary or multiple tumors in the liver
- At least one over 0.5 cm in diameter
- Edge of lesion not contiguous with main hepatic or common biliary duct.
Musculoskeletal lesions
- Local or regional recurrence of primary bone or soft tissue tumor not amenable to resection or radiotherapy
- Osseous, soft tissue or lymph node metastases not amenable to resection or radiotherapy.
- Head, neck, spine, extremity, chest wall, flank, abdominal wall, or pelvic bone or girdle lesions are treatable under this protocol
- RFA target < 50% of axial area in weight bearing bone unless reinforced with internal fixation (bone cement infusion) or in non-ambulatory patient.
Lung lesions
- No supplemental oxygenation is required.
- Metastatic solid tumor that has recurred or progressed after primary thoracotomy or thoracoscopic removal that is not amenable to radiotherapy, surgery or chemotherapy
- In the investigator's opinion, no supplemental oxygen will likely be required at rest for more than 30 days after RF ablation.
- Tumor burden < 20% of lung volume
研究計画
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 |
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実験的:1
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Radiofrequency tumor ablation (RFA) is an imaging guided percutaneous or intra-operative procedure that uses a probe on the end of a sharp needle that is inserted directly into the tumor.
The tumor is ablated by heating the probe (using electrical current alternating at radio frequency) which raises the temperature of the tumor potentially causing irreversible cell death.
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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 |
時間枠 |
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To determine the safety of RFA in patients with childhood acquired tumors
時間枠:5 years
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5 years
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協力者と研究者
捜査官
- 主任研究者:Matthew Krasin, MD、St. Jude Children's Research Hospital
出版物と役立つリンク
便利なリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Radiofrequency Tumor Ablationの臨床試験
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Farapulse, Inc.積極的、募集していない
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Pier LambiaseUniversity Hospital Southampton NHS Foundation Trust; The Royal Bournemouth Hospital完了
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University of AdelaideBoston Scientific Corporation; Medtronic; Abbott Medical Devices完了