A Pilot Study of [Ga-68]PSMA PET/MRI for the Assessment of PSMA-positive Tumors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Test-retest reproducibility of PET biomarker ([Ga68]-PSMA) uptake using PET/MRI
研究概览
简要总结
The purpose of this study is to see if positron emission tomography/ magnetic resonance imaging (PET/MRI) can be used to monitor the effectiveness of cancer treatment using an investigational radioactive drug called [Ga-68]PSMA.
详细描述
Primary Objective
The primary objective of this pilot imaging study is to determine the feasibility of using positron emission tomography/ magnetic resonance (PET/MR) with [Ga-68] prostate-specific membrane antigen (PSMA) for staging and treatment monitoring of PSMA expressing tumors. [Ga-68]PSMA PET/MR findings will be compared with standard of care imaging, patient follow up, and histopathology if available. [Ga-68]PSMA PET/MR will not be used to change the patients' treatment plan. Investigators will assess PET/MR test-retest reproducibility and compare baseline [Ga-68]PSMA PET/MR with PET/MR after initiation (within 2-6 weeks) of therapy and evaluate if [Ga-68]PSMA is a suitable biomarker for treatment monitoring and assessment of early treatment response.
Secondary Objectives
- To compare early changes in PET biomarker ([Ga-68]PSMA) tumor uptake with treatment response assessed at completion of therapy (prediction of treatment response).
- To compare changes in MRI signal intensities (multi-parametric MRI) with treatment response assessed at completion of therapy.
- To compare results from multi-parametric MR imaging with [Ga-68]PSMA uptake.
- To assess combinations of quantitative PET and MRI metrics.
Study Design Patients, who enroll in this study, will undergo a baseline [Ga-68]PSMA PET/MR to assess the level of [Ga-68]PSMA tumor uptake. Patients with positive [Ga-68]PSMA tumor uptake (defined as [Ga-68]PSMA uptake twice the background activity) who are receiving systemic therapy will undergo a further [Ga-68]PSMA PET/MR 2-6 weeks after start of treatment. Patients with positive [Ga-68]PSMA tumor uptake will also be offered to participate in a test- retest study with a 2nd [Ga-68]PSMA PET/MR prior to treatment. Patients will therefore undergo a maximum of three [Ga-68]PSMA PET/MR imaging procedures. The first two test-retest Ga-PSMA-PET/MRI will be performed on separate days to allow for radioactive decay. There will be no other (e.g. clinically indicated) PET scan performed on the same day of [Ga-68]PSMA-PET/MRI.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with PSMA-positive tumors including prostate cancer, breast cancer, lung cancer, and other tumor types know to express PSMA
- •Patients able to tolerate PET/MRI scans
- •Informed consent must be given and signed
排除标准
- •Subjects who do not meet the above mentioned inclusion criteria
- •Subjects who refuse to give and/or sign the informed consent
- •Patients who have a history of serious adverse events related to a previous MRI or PET/CT
- •Patients who are unable to undergo MRI scanning due to exclusion by institutional MRI restriction policies as mentioned in the standard institutional MRI informed consent form
- •Patients who are currently pregnant or breast feeding. A pregnancy test within 72 hours of the first PET/MRI will be performed.
- •Anti-cancer treatment (chemotherapy and/or radiation therapy) within the last 2 weeks.
- •Renal insufficiency: elevated Creatinine and/or Glomerular Filtration Rate (GFR)<40ml/min/1.7sqm (exclusion criterion only for contrast enhanced MRI)
- •Patients with a known allergy against any component of the contrast enhancing MR agent will not receive MR contrast agents. (exclusion criterion only for contrast enhanced MRI)
结局指标
主要结局
Test-retest reproducibility of PET biomarker ([Ga68]-PSMA) uptake using PET/MRI
时间窗: Up to 6 weeks after beginning treatment
The outcome measure for the statistical analysis of the test-retest reproducibility will be concordance analysis of standard uptake values (SUVs) between the 2 baseline scans
次要结局
- Ability of PET/MRI to measure changes in PET biomarker [Ga-68]PSMA) tumor uptake after initiation of therapy(Up to 6 weeks after beginning treatment)
- Comparison of changes in MRI signal intensities (multi-parametric MRI) with treatment response assessed at completion of therapy(Up to 6 weeks after beginning treatment)
- Comparison of results from multi-parametric MR imaging with [Ga-68]PSMA tumor uptake(Up to 6 weeks after beginning treatment)
- Test-retest reproducibility of quantification of MRI sequences (multi-parametric MRI)(Up to 6 weeks after beginning treatment)
- Changes in MR signal intensities after initiation of therapy(Up to 6 weeks after beginning treatment)
- Comparison of early changes in PET biomarker ([Ga68]PSMA) tumor uptake with treatment response assessed at completion of therapy(Up to 6 weeks after beginning treatment)
- Assessment of combinations of quantitative PET and MRI metrics(Up to 6 weeks after beginning treatment)