Percutaneous Cryoablation in Treating Patients With Painful Bone Metastases
Percutaneous US and CT-guided Cryoablation of Painful Metastases Involving Bone: A Feasibility Study
RATIONALE: Percutaneous cryoablation may help relieve pain caused by bone metastases.
PURPOSE: This clinical trial is studying the side effects and how well percutaneous cryoablation works in treating patients with painful bone metastases.
調査の概要
詳細な説明
OBJECTIVES:
- To confirm the safety of percutaneous cryoablation in the palliative treatment of patients with painful bone metastases.
- To determine the benefits of cryoablation of painful bone metastases by assessing pain intensity using a standardized Cleeland Brief Pain Inventory (BPI) and quality of life using a standardized SF-8 both before and after treatment.
- To determine the secondary benefits of cryoablation of painful bone metastases by assessing change in analgesic use following therapy.
- To determine the level of anesthesia required for cryoablation with a baseline level of conscious sedation planned for each treatment.
OUTLINE: This is a multicenter study.
Patients undergo percutaneous cryoablation to one or two sites of metastatic disease using the Endocare Cryocare system. Patients with a good initial response to treatment (≥ 2 decrease in pain intensity rating on the Brief Pain Inventory) who develop recurrent pain at the same site or a new painful site ≥ 1 month after initial treatment may undergo one additional cryoablation treatment.
Patients complete pain and quality of life questionnaires periodically.
After completion of study treatment, patients are followed periodically for 2 years.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
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Florida
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Jacksonville、Florida、アメリカ、32224
- Mayo Clinic - Jacksonville
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Michigan
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Ann Arbor、Michigan、アメリカ、48109-0942
- University of Michigan Comprehensive Cancer Center
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Detroit、Michigan、アメリカ、48201-1379
- Barbara Ann Karmanos Cancer Institute
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Minnesota
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Rochester、Minnesota、アメリカ、55905
- Mayo Clinic Cancer Center
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New York
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New York、New York、アメリカ、10021
- Memorial Sloan-Kettering Cancer Center
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New York、New York、アメリカ、10016
- NYU Cancer Institute at New York University Medical Center
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19104-4283
- Abramson Cancer Center of the University of Pennsylvania
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Rhode Island
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Providence、Rhode Island、アメリカ、02912
- Brown University School of Medicine
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Wisconsin
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Madison、Wisconsin、アメリカ、53792-6164
- University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
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Milwaukee、Wisconsin、アメリカ、53215
- Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed metastatic solid tumor involving or abutting bone (index lesion)
- If the nature of the metastatic disease has been previously documented, index lesion to be treated does not require further documentation (i.e., biopsy)
Pain either refractory to standard care (chemotherapy, radiotherapy, surgery, or analgesics) or patient is considered a poor candidate for conventional therapies
- Radiation oncology consult is required if the patient is considered clinically to be a candidate for conventional palliative radiotherapy
- Surgical oncology consult is required if the patient is considered clinically to be a candidate for conventional surgical treatment or is considered at risk for complications resulting from potential fracture
Initial pain score ≥ 4 on a scale of 0-10 for the question "Please rate your pain by circling the one number that best describes your pain at its worst in the past 24 hours" on the Cleeland Brief Pain Inventory
- Pain from ≤ 2 sites of metastatic disease
- No lesions with evidence for impending fracture involving a weight-bearing bone (> 50% loss of cortical bone at the site)
PATIENT CHARACTERISTICS:
- Life expectancy ≥ 2 months
- Platelet count ≥ 75,000/mm³
- ANC > 1,500/mm³ (for patients who have recently been treated with chemotherapy)
- INR ≤ 1.2
- Not pregnant or nursing
- Negative pregnancy test
PRIOR CONCURRENT THERAPY:
- More than 3 weeks since prior radiotherapy
- More than 3 weeks since initiation of a new chemotherapy regimen, including bisphosphonates
- More than 7 days since prior antiplatelet medications or clopidogrel
- More than 3 days since prior acetylsalicylic acid (aspirin), ibuprofen, or other NSAIDs
- No prior treatment of the portion of a lesion within 0.5 cm of the spinal cord or brain, within 0.5 cm of a large abdominal vessel such as the aorta or inferior vena cava, or within 1 cm of bowel or bladder
- No prior radiofrequency ablation for pain palliation of the same lesion
- No concurrent regular or low molecular weight heparin or other anticoagulants
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
- マスキング:なし(オープンラベル)
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 |
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Average difference in pre- and post-treatment worst pain score in a 24-hour period at week 8
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二次結果の測定
結果測定 |
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Average difference in pre- and post-treatment worst pain score in a 24-hour period, average pain score, and pain relief score at 6, 12, and 24 months
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Average amount of pain per patient over the observation period as represented by the area under the curve (AUC) constructed from weekly pain scores on a visual-analogue scale using a score of 0-10
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Percentage of patients who are able to reduce analgesic medications
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協力者と研究者
スポンサー
捜査官
- スタディチェア:Matthew R. Callstrom, MD, PhD、Mayo Clinic
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 (見積もり)
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。
痛みの臨床試験
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Dexa Medica Group完了
アンケート管理の臨床試験
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Assistance Publique - Hôpitaux de Paris完了
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Centre Hospitalier Universitaire de Nīmes完了
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Assistance Publique - Hôpitaux de Parisまだ募集していません