FLT PET Imaging for Cervical Cancer
2017年10月25日 更新者：Sarah McGuire、University of Iowa
'F-18 Fluorothymidine ([18F]FLT) PET Imaging for Early Evaluation of Response to Chemoradiation Therapy in Patients With Cervical Cancer
Our primary hypothesis is that [18F]FLT PET can identify active bone marrow in addition to metabolically active tumor.
This trial will use FLT-PET imaging to define areas of active bone marrow in the pelvis. The radiation plan is then designed to spare that area, in hopes of keeping the bone marrow active during therapy. Bone marrow and tumor activity will be monitored using a sequence of FLT PET scans during the course of chemotherapy and radiation therapy.
調査の概要
詳細な説明
Subjects will undergo a total of up to 5 FLT PET scans.
Subjects are randomized between two groups to reduce radiation exposure from the FLT PET scans. If bone marrow activity is not identified in one scan, further scans are cancelled until the 1-month follow up scan. This is not a randomization to compare therapeutic efficacy between two study arms. Data will be pooled for analysis as pre-specified in the study's statistical plan.
Group 1 has FLT PET scans pretreatment, after 5 radiation treatments, after 10 radiation treatments, after 15 radiation treatments, and then 1 month after completing radiation therapy.
Group 2 has FLT PET scans pretreatment, after 5 radiation treatments, after 10 radiation treatments, after 20 radiation treatments, and then 1 month after completing radiation therapy.
研究の種類
介入
入学 (実際)
6
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
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Iowa
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Iowa City、Iowa、アメリカ、52242
- Holden Comprehensive Cancer Center
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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
女性
説明
Inclusion Criteria:
- Ability to understand and willingness to sign a written informed consent document.
- Histologically confirmed stage IB2, IIA, IIB, IIIB, and IVA squamous cell carcinoma of the cervix.
- Scheduled to receive chemo-radiation for oncologic treatment.
- Karnofsky of at least 60 at time of screening
- Life expectancy of at least 6 months.
- Leukocytes at least 3,000/microL
- absolute neutrophil count at least 1,500/microL
- platelets at least 100,000/microL
- total bilirubin at maximum 1.0 mg/dL (UIHC limit of normal)
- either ALT or AST less than 2.5 times the upper limit of normal
- creatinine less than 1.5 times the upper limit of normal
- non-pregnant, non-nursing, willing to use contraception
Exclusion Criteria:
- oncology research protocol requiring full pelvic radiation (i.e., 4-field box technique) or experimental chemotherapy
- uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with the study requirements.
- subjects taking nucleoside analog medications such as those used as antiretroviral agents.
- patients who have undergone hysterectomy or will have a hysterectomy as part of their cancer therapy.
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：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：Group 2
Receives fourth [F18]Fluorothymidine (FLT) PET scan after 20 fractions of radiation therapy.
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FLT PET scan 5 mCi (+/- 10%)
他の名前：
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実験的：Group 1
Receives fourth [F18]Fluorothymidine (FLT) PET scan after 15 fractions of radiation therapy.
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FLT PET scan 5 mCi (+/- 10%)
他の名前：
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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 |
時間枠 |
|---|---|---|
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Percent Difference From Baseline IMRT Plan (%)
時間枠：Baseline (pre-treatment)
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The difference in volume of bone marrow receiving radiation using a bone-marrow-sparing radiation plan compared to a standard radiation plan (IMRT), expressed as a percentage.
Both plans are patient-specific.
Bone-marrow is identified using the baseline FLT PET/CT obtained pre-imaging.
Active bone marrow is considered to have an uptake value (SUV) of 2, 3, or 4. The standard IMRT plan was created using the criteria of the National Cancer Institute's Radiation Therapy Oncology Group study RTOG-0418.
Radiation dose bins evaluated are 5 Gray, 10 Gray, 20 Gray, and 30 Gray.
The change in dose to tumor is also provided.
A negative value indicates that more bone marrow or tissue was spared using the bone-marrow sparing plan.
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Baseline (pre-treatment)
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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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Chemotherapy Compliance
時間枠：post-treatment
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The number of participants who missed at least one prescribed chemotherapy administration due to low blood counts.
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post-treatment
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Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts
時間枠：baseline, weekly during radiation treatment for up to 5 weeks, and 30 days post treatment
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White blood cell counts measurements expressed in standardized toxicity severity grades (Common Terminology Criteria for Adverse Events, v4.03) measured weekly during combined chemotherapy and radiation therapy treatment and then once at 30 day follow-up and at 1 year follow-up
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baseline, weekly during radiation treatment for up to 5 weeks, and 30 days post treatment
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Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.
時間枠：baseline, weekly during radiation treatment for up to 5 weeks, and 30 days post treatment
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Platelet cell counts measurements expressed in standardized toxicity severity grades (Common Terminology Criteria for Adverse Events, v4.03) measured once weekly during combined chemotherapy and radiation therapy, then once at 30 day follow-up, and once at 1 year follow-up
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baseline, weekly during radiation treatment for up to 5 weeks, and 30 days post treatment
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Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)
時間枠：baseline, weekly during radiation treatment for up to 5 weeks, and 30 days post treatment
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Absolute neutrophil counts (ANCs) measurements expressed in standardized toxicity severity grades (Common Terminology Criteria for Adverse Events, v4.03) measured once weekly during combined chemotherapy and radiation therapy, then once at 30 day follow-up, and once at 1 year follow-up.
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baseline, weekly during radiation treatment for up to 5 weeks, and 30 days post treatment
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Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.
時間枠：baseline, weekly during radiation treatment for up to 5 weeks, and 30 days post treatment
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Lymphocyte counts measurements expressed in standardized toxicity severity grades (Common Terminology Criteria for Adverse Events, v4.03) measured once weekly during combined chemotherapy and radiation therapy, then once at 30 day follow-up, and once at 1 year follow-up
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baseline, weekly during radiation treatment for up to 5 weeks, and 30 days post 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。
スポンサー
捜査官
- スタディディレクター：Michael M Graham, Ph.D., M.D.、University of Iowa
- 主任研究者：Sarah McGuire, Ph.D.、University of Iowa
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- McGuire SM, Menda Y, Ponto LL, Gross B, Juweid M, Bayouth JE. A methodology for incorporating functional bone marrow sparing in IMRT planning for pelvic radiation therapy. Radiother Oncol. 2011 Apr;99(1):49-54. doi: 10.1016/j.radonc.2011.01.025. Epub 2011 Mar 22.
- McGuire SM, Menda Y, Boles Ponto LL, Gross B, Buatti J, Bayouth JE. 3'-deoxy-3'-[(1)(8)F]fluorothymidine PET quantification of bone marrow response to radiation dose. Int J Radiat Oncol Biol Phys. 2011 Nov 1;81(3):888-93. doi: 10.1016/j.ijrobp.2010.12.009. Epub 2011 Feb 6. Erratum In: Int J Radiat Oncol Biol Phys. 2012 Sep 1;84(1):7.
- Menda Y, Ponto LL, Dornfeld KJ, Tewson TJ, Watkins GL, Gupta AK, Anderson C, McGuire S, Schultz MK, Sunderland JJ, Graham MM, Buatti JM. Investigation of the pharmacokinetics of 3'-deoxy-3'-[18F]fluorothymidine uptake in the bone marrow before and early after initiation of chemoradiation therapy in head and neck cancer. Nucl Med Biol. 2010 May;37(4):433-8. doi: 10.1016/j.nucmedbio.2010.02.005.
- McGuire SM, Bhatia SK, Sun W, Jacobson GM, Menda Y, Ponto LL, Smith BJ, Gross BA, Bayouth JE, Sunderland JJ, Graham MM, Buatti JM. Using [(18)F]Fluorothymidine Imaged With Positron Emission Tomography to Quantify and Reduce Hematologic Toxicity Due to Chemoradiation Therapy for Pelvic Cancer Patients. Int J Radiat Oncol Biol Phys. 2016 Sep 1;96(1):228-39. doi: 10.1016/j.ijrobp.2016.04.009. Epub 2016 Apr 19.
- McGuire SM, Menda Y, Ponto LLB, Gross B, TenNapel M, Smith BJ, Bayouth JE. Spatial mapping of functional pelvic bone marrow using FLT PET. J Appl Clin Med Phys. 2014 Jul 8;15(4):129-136. doi: 10.1120/jacmp.v15i4.4780.
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 (実際)
2009年9月1日
一次修了 (実際)
2016年3月3日
研究の完了 (実際)
2016年4月11日
試験登録日
最初に提出
2010年2月23日
QC基準を満たした最初の提出物
2010年2月23日
最初の投稿 (見積もり)
2010年2月25日
学習記録の更新
投稿された最後の更新 (実際)
2017年12月2日
QC基準を満たした最後の更新が送信されました
2017年10月25日
最終確認日
2017年10月1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。
[F18]Fluorothymidineの臨床試験
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Assistance Publique Hopitaux De Marseilleわからない
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Radboud University Medical CenterABX advanced biochemical compounds GmbH; Radboud Translational Medicine募集
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