NCT06743100No Longer Available不适用
An Expanded Access Program for the Non-invasive Characterization of Glioma or Treatment Related Change Utilizing Fluorine (F-18) Floretyrosine (18F-FET, TLX101-CDx)
Telix Pharmaceuticals (Innovations) Pty Limited17 个研究点 分布在 1 个国家开始时间: 2024年12月19日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- No Longer Available
- 发起方
- 试验地点
- 17
研究概览
简要总结
The aim of this Expanded Access Program (EAP) is to enable the use of 18F-Floretyrosine with positron emission tomography/computed tomography (PET/CT) or positron emission tomography/magnetic resonance (PET/MR) imaging to noninvasively detect tumor burden or treatment related change to assist in optimal management of patients with glioma.
研究设计
- 研究类型
- Expanded Access
入排标准
- 年龄范围
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written and voluntarily given informed consent. Pediatric patients (<18 years of age) will provide assent along with parental/legal guardian /caregiver consent according to IRB requirements.
- •Male or female ≥ 3 years of age at time of consent/assent
- •Diagnosis or clinical suspicion of glioma (any grade) in the brain
- •At the time of screening have undergone therapy for glioma
- •Indeterminate MR findings for disease recurrence or progression versus treatment related changes (pseudoprogression or pseudoresponse) requiring further diagnostic procedures within 60 days prior to the 18F-Floretyrosine PET imaging
- •Willing and able to lie still for at least 40 minutes in an enclosed space for the imaging procedure, or if medically necessary, able to tolerate standard institutions procedures for sedation and/or anesthesia.
排除标准
- •Participant cannot be safely scanned due to devices, implants, foreign and/or metallic objects in or on the body that are not MR compatible, unless a clinical judgement is made that the participant's diagnostic needs can instead be met by diversion to 18F-Floretyrosine imaging by PET/CT (making the magnetic field compatibility an irrelevant safety concern).
- •Women who are pregnant or breastfeeding.
- •Women of childbearing potential who are unwilling or unable to use an acceptable method of contraception to avoid pregnancy for the duration of the program (Day 0 to Day 2).
- •Serious non-malignant disease (e.g., psychiatric, infectious, autoimmune, or metabolic), that may interfere with the objectives of the program or with the safety or compliance of the participant, as judged by the Investigator.
- •Mental impairment that may compromise the ability to give informed consent/assent and comply with the requirements of the program as judged by the Investigator.
- •Exposure to any experimental diagnostic or therapeutic drug within 30 days from the date planned administration of 18F-Floretyrosine.
- •Known hypersensitivity to floretyrosine or tyrosine derivatives.
- •Unable to tolerate the program procedures.
研究者
研究点 (17)
Loading locations...
相似试验
招募中
2 期
Utility of 18FDOPA PET/MRI for Focal HyperinsulinismHyperinsulinismNCT05088798Washington University School of Medicine100
已完成
不适用
18F-fluorodeoxyglucose (18F-FDG) Positron Emission Tomography in OncologyBrain NeoplasmsLung NeoplasmsLymphomaColorectal NeoplasmsMelanomaNCT00207298British Columbia Cancer Agency39,242
已完成
4 期
Study to Evaluate the Feasibility of [18F]Florbetapir PET for Assessment in MS PatientsMultiple SclerosisNCT01767493Institute for Neurodegenerative Disorders19
招募中
不适用
Molecular Pituitary Imaging Using 18F-FET PETPituitary AdenomaNCT06584123University of Cambridge20
招募中
2 期
An Investigational Scan (18F-DOPA PET/CT) for Improving the Clinical Management of Brain TumorsMalignant Brain NeoplasmNCT06667726Mayo Clinic47