18F-FLT-PET Imaging of the Brain in Patients With Metastatic Breast Cancer to the Brain Treated With Whole Brain Radiation Therapy With or Without Sorafenib: Comparison With MR Imaging of the Brain
Pilot Study of 18F-FLT-PET Imaging of the Brain in Patients With Metastatic Breast Cancer to the Brain Treated With Whole Brain Radiation Therapy With or Without Sorafenib: Comparison With MR Imaging of the Brain
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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New Jersey
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Basking Ridge、New Jersey、アメリカ
- Memoral Sloan Kettering Cancer Center
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Middletown、New Jersey、アメリカ、07748
- Memorial Sloan Kettering Monmouth
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New York
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Commack、New York、アメリカ、11725
- Memorial Sloan Kettering Cancer Center @ Suffolk
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Harrison、New York、アメリカ、10604
- Memorial Sloan Kettering Westchester
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New York、New York、アメリカ、10065
- Memorial Sloan Kettering Cancer Center
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Rockville Centre、New York、アメリカ
- Memorial Sloan Kettering at Mercy 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
Inclusion Criteria:
- Histologically-confirmed (confirmation done at MSKCC) metastatic adenocarcinoma of the breast
- Radiologic evidence of new and/or progressive brain metastases ((≥10 mm in longest dimension) by MRI imaging of the Brain
- Planned WBRT based on number (≥ 3 lesions) and/or size (≥ 1 cm) of brain metastases.
- Age ≥18 years; males and females
- Patients who require additional clinically indicated stereotactic radiosurgery (SRS) in addition to WBRT will also be eligible.
- Life expectancy of >12 weeks.
- Karnofsky Performance Status (KPS) ≥ 70%.
- Creatinine ≤2.0 times the upper limit of normal.
- Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to enrollment, must be non-lactating and must agree to use adequate contraception prior to enrollment and for the duration of study participation.
- No limit to prior therapies with last anti-cancer treatment ≥2 weeks from initiation of WBRT. Please note: there is no washout period required for trastuzumab, pertuzumab, for patients who have developed new parenchymal brain metastases while on these agents.
Exclusion Criteria:
- Leptomeningeal metastases Please note: leptomeningeal metastases may be allowed if it is limited to cranial metastasis (MRI spine should be completed, within 4 weeks of enrollment, to show that no other leptomeningeal metastases is present) and is not the only metastasis present in the brain.
- Concurrent administration of lapatinib or other tyrosine kinase inhibitors other than sorafenib
- Craniotomy or any other major surgery, open biopsy, or significant traumatic injury within 4 weeks of randomization.
- Concurrent anti-cancer therapy (chemotherapy, hormonal therapy, radiation therapy, surgery, immunotherapy, biologic therapy, or tumor embolization) other than sorafenib, and protocol-specified whole-brain radiotherapy.
- Use of any investigational drug within 30 days or 5 half-lives, whichever is longer, preceding enrollment.
- Inability to comply with protocol and /or not willing or not available for follow-up assessments.
- Any condition which in the investigator's opinion makes the patient unsuitable for the study participation.
- Patient is incontinent of urine or stool (which would make them unable to tolerate lying still for 60 minutes).
- Claustrophobia
- Known allergic reaction to Gd-DTPA
- Renal insufficiency with recent (<3 month old) creatinine >2.0
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:診断
- 割り当て:非ランダム化
- 介入モデル:並列代入
- 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:Cohort 1
Cohort 1 will include the first ten patients treated with WBRT concomitantly with sorafenib (on a separate phase I trial).
We will perform a pilot study of serial FLT-PET imaging of the brain at baseline (< 4 weeks prior to initiation of WBRT), up to 7-10 days post-WBRT and 10-12 weeks after WBRT in patients with metastatic breast cancer to the brain (N=20) treated with WBRT with or without sorafenib.
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All patients will be imaged using FLT-PET scans at baseline (within 4 weeks of initiation of WBRT), 7-10 days after completion of WBRT and then 10-12 weeks after WBRT. Patients will also be evaluated with MRI imaging at baseline and then 10-12 weeks after WBRT. Patients will be followed with MRI every 3 months (+/- 7 days) for the first year and then every 6 months (+/- 7 days) thereafter which is the standard of care. |
実験的:Cohort 2
Cohort 2 will include patients treated with standard WBRT alone.
Patients in both these cohorts will also be assessed with standard non-invasive MRI in addition to [18F] FLT PET at baseline (< 4 weeks of WBRT) and 10-12 weeks after completion of WBRT.
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All patients will be imaged using FLT-PET scans at baseline (within 4 weeks of initiation of WBRT), 7-10 days after completion of WBRT and then 10-12 weeks after WBRT. Patients will also be evaluated with MRI imaging at baseline and then 10-12 weeks after WBRT. Patients will be followed with MRI every 3 months (+/- 7 days) for the first year and then every 6 months (+/- 7 days) thereafter which is the standard of care. |
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 |
時間枠 |
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Overall Response Rate
時間枠:1 year
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Overall Response Rate is the proportion of participants who had a complete or partial response (Cohort 1)
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1 year
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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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Change in Avg SUV Max From Baseline to 1 Year
時間枠:1 year
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Comparing FLT PET findings with tissue analysis will enable us to determine if imaging results are concordant with histological findings and thus allow for confirmation of this hypothesis.
In this manner, we propose to generate a bridge between tissue analysis and FLT-PET brain imaging studies.
For patients needing to undergo craniotomy for resection of a brain metastasis after WBRT, tissue findings (radionecrosis versus viable tumor) will be correlated with radiologic assessment in an exploratory manner.
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1 year
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協力者と研究者
捜査官
- 主任研究者:Andrew Seidman, MD、Memorial Sloan Kettering Cancer Center
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
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。
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