GA-68 PSMA-11 PET To Evaluate Malignant Glioma Recurrence - A Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Adverse Events (safety and tolerability)
研究概览
简要总结
This clinical trial evaluates whether gallium-68 (Ga-68) prostate specific membrane antigen (PSMA)-11 positron emission tomography (PET)/computed tomography (CT) imaging is useful in differentiating between disease that has come back after a period of improvement (recurrence) or that is growing, spreading, or getting worse (progression) and treatment effect in patients with glioma. Patients with glioma undergo frequent imaging for assessment of disease status. After first-line treatment however, the correlation between imaging findings and tumor activity can be confused, and surgery is often required for definitive diagnosis. The PET/CT scanner is an imaging machine that combines 2 types of imaging in a single scan. The PET scanner detects and takes pictures of where the radioactive imaging agent (68Ga PSMA-11) has gone in the body and the CT scanner uses x-rays to take structural pictures inside the body. PSMA PET also binds to neoplastic blood vessels, including those in gliomas. This study may help researchers learn whether GA-68 PSMA-11 PET/CT is useful for improving detection of tumor recurrence or progression, as opposed to treatment effects, in patients with gliomas.
详细描述
PRIMARY OBJECTIVE:
I. To assess the feasibility and immediate safety profile of gallium Ga 68 gozetotide (Ga-68 labeled PSMA-11) brain PET in patients with gliomas, assessed as the percentage of patients who experience grade 3 or higher adverse effects deemed to be at least possibly related to PSMA-11 occurring prior to the patient leaving the Nuclear Medicine department.
EXPLORATORY OBJECTIVES:
I. An exploratory investigation will be performed in regions of high tumor cell density (tumor recurrence) and low tumor cell density/treatment effect to determine whether PSMA-11 uptake differs significantly between true tumor progression vs. in radiation treatment effects by performing a radiology-pathology comparison of visual and descriptive features of the PET with biopsy.
II. To identify optimal maximum standardized uptake value (SUVmax) thresholds for differentiating viable tumor from treatment effect.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Age ≥ 18 years.
- •History of World Health Organization (WHO) grade III or IV infiltrating glioma previously treated with first-line chemoradiotherapy.
- •MRI findings compatible with contrast-enhancing recurrent infiltrating glioma.
- •Planned biopsy or resection of suspected disease recurrence.
- •Willing to sign release of information for any radiation and/or follow-up records.
- •Ability to provide informed written consent.
- •Ability to provide tissue for mandatory correlative research component.
排除标准
- •Unable to undergo a PSMA PET/CT scan (e.g. body habitus, claustrophobia).
- •Any of the following:
- •Pregnant women
- •Nursing women
- •Men or women of childbearing potential unwilling to employ adequate contraception
研究组 & 干预措施
Diagnostic (Ga-68 PSMA-11, PET/CT)
Patients receive Ga-68 PSMA-11 IV and then undergo PET/CT over 1 hour, 50-100 minutes after injection.
干预措施: Computed Tomography (Procedure)
Diagnostic (Ga-68 PSMA-11, PET/CT)
Patients receive Ga-68 PSMA-11 IV and then undergo PET/CT over 1 hour, 50-100 minutes after injection.
干预措施: Positron Emission Tomography (Procedure)
Diagnostic (Ga-68 PSMA-11, PET/CT)
Patients receive Ga-68 PSMA-11 IV and then undergo PET/CT over 1 hour, 50-100 minutes after injection.
干预措施: Ga 68 PSMA-11 (Drug)
Diagnostic (Ga-68 PSMA-11, PET/CT)
Patients receive Ga-68 PSMA-11 IV and then undergo PET/CT over 1 hour, 50-100 minutes after injection.
干预措施: Electronic Health Record Review (Other)
结局指标
主要结局
Adverse Events (safety and tolerability)
时间窗: Up to 24 hours after 68Ga-PSMA-11 injection
Assessed as the percentage of patients who experience Grade 3 or higher adverse effects deemed to be at least possibly related to PSMA-11. Adverse effects will be assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.
Tolerability of PSMA positron emission tomography scan
时间窗: Up to 60 days
Will assess any issues in completion of the PSMA positron emission tomography scans in these patients and summarize those in a descriptive manner.
次要结局
未报告次要终点