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
연구 개요
상세 설명
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.
연구 유형
등록 (예상)
단계
- 1단계
연락처 및 위치
연구 연락처
- 이름: Dustin R Osborne, PHD
- 전화번호: 8653058264
- 이메일: DOSBORNE@UTMCK.EDU
연구 연락처 백업
- 이름: Melissa Weaver
- 전화번호: 8653056181
- 이메일: mweaver@utmck.edu
연구 장소
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Tennessee
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Knoxville, Tennessee, 미국, 37920
- 모병
- University of Tennessee Medical Center
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연락하다:
- Shelley Acuff
- 전화번호: 8653056312
- 이메일: sacuff@utmck.edu
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연락하다:
- Melissa Weaver
- 전화번호: 865-305-6181
- 이메일: mweaver@utmck.edu
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수석 연구원:
- Dustin Osborne, PhD
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수석 연구원:
- Joseph Kelley, MD
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수석 연구원:
- Francis J Turner, MD
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부수사관:
- Yitong Fu, MD
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부수사관:
- Jacob Noe, MD
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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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실험적: 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
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Biodistribution of 18F-AraG
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Assessment of biodistribution and kinetics differences between study arms
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Dustin Osborne, PhD, University of Tennessee
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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