Biodistribution and Kinetics of 18F-AraG in Non-Small Cell Lung Cancer
Biodistribution and Kinetics of 18F-AraG in Non-Small Cell Lung Cancer Patients Before and After Immunotherapy With and Without Radiation
調査の概要
詳細な説明
The overall goal of this project is to evaluate the ability of [18F]-AraG, a novel T-cell activation imaging biomarker, to measure T-cell activation before and after treatment with programmed death (PD) PD-1/PD-L1 inhibition and with PD-1/PD-L1 inhibition plus radiation therapy in NSCLC patients. Early preclinical and clinical studies have shown promise for immunotherapy treatments for several malignancies [1]. Immunotherapy is expected to grow in importance; however, it presents difficult challenges for response assessment. For instance, successfully treated tumors may actually increase in size after therapy due to inflammation and only later shrink [2]. RECIST criteria [3] designed to detect early effects of cytotoxic agents by size reduction, or the more recently proposed immune-related response criteria (irRC) [4] do not allow an early assessment of immunotherapeutic response since both depend on tumor size change. Furthermore, FDG PET is confounded by inflammatory effects causing hypermetabolism [5] [6]. Thus, it is imperative to develop new imaging and analysis protocols to evaluate immune-checkpoint blockade approaches. A method that evaluates T cell activation would permit an assessment of a basic first step in the process of assessing immunotherapy efficacy.
There are two main goals associated with this project. We propose to 1) assess the [18F]-AraG biodistribution and kinetics, in non-small cell lung cancer (NSCLC) tumor(s) and tumor draining lymph nodes on [18F]-AraG PET/CT imaging before and after 1 course of immunotherapy and 1 course of immunotherapy plus radiation 2) correlate (potential) change in [18F]-AraG uptake within the tumor(s) or tumor draining lymph nodes with clinical and pathologic response in patients treated with immunotherapy.
研究の種類
入学 (予想される)
段階
- フェーズ 1
連絡先と場所
研究連絡先
- 名前：Dustin R Osborne, PHD
- 電話番号：8653058264
- メール：DOSBORNE@UTMCK.EDU
研究連絡先のバックアップ
- 名前：Melissa Weaver
- 電話番号：8653056181
- メール：mweaver@utmck.edu
研究場所
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Tennessee
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Knoxville、Tennessee、アメリカ、37920
- 募集
- University of Tennessee Medical Center
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コンタクト：
- Shelley Acuff
- 電話番号：8653056312
- メール：sacuff@utmck.edu
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コンタクト：
- Melissa Weaver
- 電話番号：865-305-6181
- メール：mweaver@utmck.edu
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主任研究者：
- Dustin Osborne, PhD
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主任研究者：
- Joseph Kelley, MD
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主任研究者：
- Francis J Turner, MD
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副調査官：
- Yitong Fu, MD
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副調査官：
- Jacob Noe, MD
-
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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:
- This study is open to all adult subjects with histological confirmation of NSCLC enrolled in the parent protocol.
- Age 21 years of age or greater
- ECOG performance status of 0, 1, 2 or 3 at the time of enrollment.
- Patient with life expectancy ≥ 24 weeks from the time of screening to the study
- Ability to give informed consent
Exclusion Criteria:
- Patients with severe claustrophobia (patients with milder forms of claustrophobia that can be successfully allayed with oral anxiolytic therapy are allowed).
- Severe impaired renal function with estimated glomerular filtration rate <30 mL/min/1.73 m2 and/or on dialysis.
- Pregnancy
- Breast Feeding an infant
- Unable to tolerate the expected radiation therapy prescription
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：基礎科学
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：独身
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：NSCLC with Immunotherapy without radiation
The biodistribution and kinetics of the 18F-AraG compound will be assessed in non-small cell lung cancer patients undergoing immunotherapy without adjuvant radiation therapy
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All arms of the study will receive an injection of 18F-AraG while on the PET imaging system.
Following a 6 minute scan over the heart to acquire input function data, the patient will undergo a 1 hour multi-pass whole-body dynamic PET/CT acquisition to gather whole-body biodistribution data.
|
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実験的：NSCLC with Immunotherapy with radiation
The biodistribution and kinetics of the 18F-AraG compound will be assessed in non-small cell lung cancer patients undergoing immunotherapy with adjuvant radiation therapy
|
All arms of the study will receive an injection of 18F-AraG while on the PET imaging system.
Following a 6 minute scan over the heart to acquire input function data, the patient will undergo a 1 hour multi-pass whole-body dynamic PET/CT acquisition to gather whole-body biodistribution data.
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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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Biodistribution of 18F-AraG
時間枠：Up to 90 minutes post injection of 18F-AraG
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Assessment of the distribution of 18F-AraG in patients with non-small cell lung cancer using activity concentration
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Up to 90 minutes post injection of 18F-AraG
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Kinetics of 18F-AraG
時間枠：Up to 90 minutes post injection of 18F-AraG
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Assessment of the rate of uptake using activity concentration of 18F-AraG in regions found to have significant AraG uptake
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Up to 90 minutes post injection of 18F-AraG
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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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Assessment of biodistribution and kinetics differences between study arms
時間枠：6 months
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Assessment of biodistribution and kinetics differences using activity concentration changes between patients undergoing immunotherapy with radiation and immunotherapy without radiation
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6 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：Dustin Osborne, PhD、University of Tennessee
出版物と役立つリンク
一般刊行物
- Franc BL, Goth S, MacKenzie J, Li X, Blecha J, Lam T, Jivan S, Hawkins RA, VanBrocklin H. In Vivo PET Imaging of the Activated Immune Environment in a Small Animal Model of Inflammatory Arthritis. Mol Imaging. 2017 Jan 1;16:1536012117712638. doi: 10.1177/1536012117712638.
- Ronald JA, Kim BS, Gowrishankar G, Namavari M, Alam IS, D'Souza A, Nishikii H, Chuang HY, Ilovich O, Lin CF, Reeves R, Shuhendler A, Hoehne A, Chan CT, Baker J, Yaghoubi SS, VanBrocklin HF, Hawkins R, Franc BL, Jivan S, Slater JB, Verdin EF, Gao KT, Benjamin J, Negrin R, Gambhir SS. A PET Imaging Strategy to Visualize Activated T Cells in Acute Graft-versus-Host Disease Elicited by Allogenic Hematopoietic Cell Transplant. Cancer Res. 2017 Jun 1;77(11):2893-2902. doi: 10.1158/0008-5472.CAN-16-2953.
- Levi J, Lam T, Goth SR, Yaghoubi S, Bates J, Ren G, Jivan S, Huynh TL, Blecha JE, Khattri R, Schmidt KF, Jennings D, VanBrocklin H. Imaging of Activated T Cells as an Early Predictor of Immune Response to Anti-PD-1 Therapy. Cancer Res. 2019 Jul 1;79(13):3455-3465. doi: 10.1158/0008-5472.CAN-19-0267. Epub 2019 May 7.
- Namavari M, Chang YF, Kusler B, Yaghoubi S, Mitchell BS, Gambhir SS. Synthesis of 2'-deoxy-2'-[18F]fluoro-9-beta-D-arabinofuranosylguanine: a novel agent for imaging T-cell activation with PET. Mol Imaging Biol. 2011 Oct;13(5):812-8. doi: 10.1007/s11307-010-0414-x.
研究記録日
主要日程の研究
研究開始 (実際)
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 (実際)
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
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