Dynamic PET CT as a Tool for Treatment Efficacy Monitoring in Lung Cancer
調査の概要
状態
条件
詳細な説明
Background:
Lung cancer is a devastating disease in which the response for first line therapy is only 30%. Evaluating response is performed normally by a CT or PET-CT scans after 2-3 cycles of therapy, thus, lack of response is been evaluated only after the patient has been treated following significant amount of therapy, which is inefficient in 70% of cases.
Therefore, there is an urgent need to develop tools that might predict response to therapy during the early course of therapy; Most valuable will be before or after the first cycle of therapy. For that reason, the investigators aim in this study to evaluate the use of Dynamic PET-CT as a tool to assess disease response to anti-cancer therapy in Lung Cancer patients.
Objectives:
- To assess the feasibility of baseline Dynamic PET-CT as a tool for assessing response for anti-cancer therapy in Lung Cancer patients.
- To predict early response to treatment as soon as after 1 cycle of therapy by dynamic and static PET-CT.
- To correlate Dynamic PET-CT with survival/disease free survival
Method:
200 advanced lung cancer patients will be enrolled over 3 years in a single institute, single arm study at Rabin Medical Center, Beilinson Hospital.
Patients will be evaluated by a Dynamic PET-CT protocol: before initiation of therapy, 7-14 days after the first therapy cycle, 3 months after initiation of therapy and 6 months after the first therapy cycle. In addition, non-invasive biomarkers that are routinely measured including protein markers (CEA- Carcinoembryonic Antigen, CYFRA21- Cytokeratin 19 Fragment, NSE- Neuron Specific Enolase) will be assessed in this trial.
Disease response will be evaluated by Response Evaluation Criteria In Solid Tumors (RECIST criteria).
Additional PET-CT will not increase radiation dose significantly. The mean estimated radiation dose for a limited CT of the chest is about 14 mSv (i.e., 7mSv for limited diagnostic CT and FDG ([18F]-fluorodeoxyglucose), each). The dynamic stage will add radiation dose of about 0.3mSv. Of note, the significance of adding radiation dose is less of importance with regard to treatment of patients with aggressive cancer.
研究の種類
入学 (予想される)
連絡先と場所
研究場所
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Petach Tikva、イスラエル、49100
- Rabin 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
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Age > 18 years.
- Lung cancer, stage 4
- Patients are planned to be treated by a systemic anti-cancer therapy.
- A define lesion for imaging.
- Able and willing to sign an informed consent form.
- First line therapy or at least 6 weeks after previous line of therapy
Exclusion Criteria:
- Pregnant or lactating women.
- Anti cancer therapy within the last 6 weeks before enrollment.
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
コホートと介入
グループ/コホート |
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Lung cancer
People that were diagnosed with advanced lung cancer.
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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 |
---|---|
Compare baseline PET-CT with PET-CT after 7-14 days.
時間枠:12 months
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12 months
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二次結果の測定
結果測定 |
時間枠 |
---|---|
Evaluate disease-free survival (DFS) in lung cancer by using dynamic PET-CT.
時間枠:12 months
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12 months
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Evaluate overall survival rate (OS) in lung cancer by using dynamic PET-CT.
時間枠:12 months
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12 months
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Measuring response to treatment by PET-CT.
時間枠:12 months
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12 months
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Nir Peled, MD PhD FCCP、Rabin Medical Center
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
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。
肺癌の臨床試験
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