Pilot Study Evaluating PSMA PET For Metastatic Adenoid Cystic Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Treatment response assessment (Feasibility)
研究概览
简要总结
This phase II trial tests whether gallium-68 (Ga-68) prostate specific membrane antigen (PSMA)-11 positron emission tomography (PET)/computed tomography (CT) imaging is useful for detecting therapy response in patients with adenoid cystic carcinoma (salivary gland cancer) that has spread from where it first started (primary site) to other places in the body (metastatic). The PET scan detects and takes pictures of where the radioactive imaging agent (68Ga PSMA-11) has gone in the body and the CT scan uses x-rays to create images of the bones and internal organs within the body. Combining a PET scan with a CT scan can help make the images easier to interpret. This study may help researchers learn whether GA-68 PSMA-11 PET/CT is useful for detecting treatment response and guiding treatment decisions in patients with metastatic adenoid cystic carcinoma.
详细描述
PRIMARY OBJECTIVES:
I. Evaluate the feasibility of serial Ga-68 PSMA PET/CT for response assessment in metastatic adenoid cystic carcinoma.
II. Assess the correlation of PSMA PET/CT response assessment with serum extracellular vesical (EV) PSMA levels for patients undergoing treatment for metastatic adenoid cystic carcinoma.
OUTLINE:
Patients receive Ga-68 PSMA-11 intravenously (IV) and then undergo PET/CT 50-70 minutes after injection at baseline and approximately 12-20 weeks during investigational therapy.
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
- •≥ 18 years of age
- •Diagnosis of metastatic adenoid cystic carcinoma
- •Enrolled in protocol MC200708
- •Ability to tolerate a Ga68 PSMA PET/CT imaging study
- •Willingness to return for a second PSMA PET/CT scan in approximately 12-20 weeks from the baseline PET/CT
- •Ability to give appropriate consent or have an appropriate representative available to do so
排除标准
- •Unable to undergo PET/CT scan
- •Not a participant in MC200708
- •< 18 years of age
- •Persons who are pregnant or nursing
- •Persons unable to consent to the study
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 50-70 minutes after injection at baseline and approximately 12-20 weeks during investigational therapy.
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 50-70 minutes after injection at baseline and approximately 12-20 weeks during investigational therapy.
干预措施: Electronic Health Record Review (Other)
Diagnostic (Ga-68 PSMA-11, PET/CT)
Patients receive Ga-68 PSMA-11 IV and then undergo PET/CT 50-70 minutes after injection at baseline and approximately 12-20 weeks during investigational therapy.
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 50-70 minutes after injection at baseline and approximately 12-20 weeks during investigational therapy.
干预措施: Positron Emission Tomography (Procedure)
结局指标
主要结局
Treatment response assessment (Feasibility)
时间窗: Up to 20 weeks
Data from the prostate specific membrane antigen (PSMA) positron emission tomography (PET)/computerized tomography (CT) exams will be categorized into treatment response categories for each participant using the Response Evaluation Criteria in PSMA PET/CT (RECIP) 1.0 criteria. Tumor volume with PSMA expression on PET/CT will be quantified using MIM Software Version 7.2.7.
Response assessment category and percent change in tumor volume
时间窗: Up to 20 weeks
Will be correlated to percent change in serial PSMA extracellular vesical (EV) from serum measurements from participant data obtained in the MC200708 trial protocol. For continuous measurements (like percent change), scatter plots and simple linear regression will be conducted. Associations of these continuous variables will be done via the Spearman's rank correlation coefficient. For assessment of changes, will use Wilcoxon Signed-Rank test. For any associations of categorical variables, will use the Fisher's Exact test.
Incidence of adverse events
时间窗: Up to 20 weeks
Will be assessed by the number of adverse event incidents reported. Safety will be categorized using the the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
次要结局
- Percentage change of mean standardized uptake value (SUV) of index lesions(Up to 20 weeks)
- Percentage change of PSMA-avid tumor volume(Up to 20 weeks)