Translating Hyperpolarized 13C MRI as a Novel Tool to Predict Treatment Response in Pancreatic Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Proportion of participants with best objective response (Cohorts A and B)
研究概览
简要总结
This study evaluates an investigational scan called hyperpolarized carbon-13 pyruvate magnetic resonance imaging (MRI) in assessing treatment response in patients with pancreatic ductal carcinoma (PDA) that has spread to nearby tissue or lymph nodes (locally advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). MRI is a standard scan that helps doctors see tumors, organs, tissue, and bone. Standard contrast agents (e.g., gadolinium) are sometimes used to help make the scan images brighter, or easier to see. Hyperpolarized carbon-13 pyruvate is an experimental contrast agent that is different from standard MRI contrast in that it provides information on how a tumor processes nutrients. Hyperpolarized carbon-13 pyruvate MRI scans may work better than MRI with standard contrast agents in predicting how PDA tumors respond to treatment.
详细描述
PRIMARY OBJECTIVES:
I. To determine the percent changes in target tumor (primary tumor and/or abdominal metastases) hyperpolarized carbon C 13 pyruvate (HP 13C pyruvate) metabolism measures between the pre-treatment scan and the scan obtained 4 weeks (± 2 weeks) following treatment initiation. (Cohorts A and B).
II. To determine whether the changes in these metabolism measures are associated with best objective response (as defined by Response Evaluation Criteria in Solid Tumors [RECIST] version [v]1.1) on subsequent clinical computed tomography (CT) scans. (Cohorts A and B).
SECONDARY OBJECTIVES:
I. In patients who proceed to surgery following neoadjuvant therapy (NAT), to determine whether the HP 13C pyruvate metabolism in the primary tumor on the pre-operative MRI or the change in HP 13C pyruvate metabolism are associated with pathological response. (Cohort B).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Participants must be 18 years or older.
- •Histological or cytological confirmation of pancreatic ductal adenocarcinoma (PDA).
- •Locally advanced or metastatic disease.
- •At least one target lesion in the abdomen measuring ≥ 1centimeter (cm), according to RECIST v1.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2 (Karnofsky ≥ 50%)
- •Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or endpoints of this study are eligible.
- •Ability to understand and willingness to sign a written informed consent document.
排除标准
- •Participants unwilling or unable to undergo magnetic resonance (MR) imaging, including patients with contra-indications to MRI, such as cardiac pacemakers or non-compatible intracranial vascular clips.
- •Poorly controlled hypertension, defined as either systolic > 170 or diastolic >
- •The addition of anti-hypertensives to control blood pressure is allowed for eligibility determination.
- •Congestive Heart Failure ≥ Class III.
- •Participants who are pregnant.
- •Individuals of childbearing potential must agree to undergo a urine pregnancy test prior to participating in the study scans. Pregnant individuals are excluded because there is an unknown but potential risk for adverse effects in the unborn child secondary to administration of HP 13C pyruvate to the study participant. A female is considered to not be of childbearing potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice), if they meet either of the following two criteria: (1) has reached a postmenopausal state (>= 12 continuous months of amenorrhea with no identified cause other than menopause); or (2) has undergone surgical sterilization (i.e., hysterectomy and/or bilateral oophorectomy for removal of uterus and/or ovaries).
- •Participants who are breastfeeding/chestfeeding. Breastfeeding/chestfeeding individuals are excluded because there is an unknown but potential risk for adverse effects in the unborn/nursing child secondary to administration of HP 13C pyruvate to the study participant. Breastfeeding/chestfeeding should be discontinued before administration of HP 13C pyruvate.
- •Known hypersensitivity to HP 13C pyruvate or any of its excipients.
- •Participants with any condition or social circumstance that, in the opinion of the investigator, would impair the participant's ability to comply with study procedures
研究组 & 干预措施
Cohort A (HP 13C pyruvate, MRI)
Participants with advanced/non-resectable pancreatic ductal adenocarcinoma (PDA) receive HP 13C pyruvate intravenously (IV) and undergo MRI scans prior to receiving standard-of-care (SOC) treatment and again at 4 weeks after starting SOC treatment. Participants may optionally undergo an additional HP 13C pyruvate MRI scan at 8 weeks after starting SOC treatment. Participants who have excellent response and deemed candidates for surgical resection may be switched to Cohort B. Participants also undergo CT and additional MRI scans throughout the study.
干预措施: Hyperpolarized 13C-Pyruvate (Drug)
Cohort A (HP 13C pyruvate, MRI)
Participants with advanced/non-resectable pancreatic ductal adenocarcinoma (PDA) receive HP 13C pyruvate intravenously (IV) and undergo MRI scans prior to receiving standard-of-care (SOC) treatment and again at 4 weeks after starting SOC treatment. Participants may optionally undergo an additional HP 13C pyruvate MRI scan at 8 weeks after starting SOC treatment. Participants who have excellent response and deemed candidates for surgical resection may be switched to Cohort B. Participants also undergo CT and additional MRI scans throughout the study.
干预措施: Computed tomography (CT) (Procedure)
Cohort A (HP 13C pyruvate, MRI)
Participants with advanced/non-resectable pancreatic ductal adenocarcinoma (PDA) receive HP 13C pyruvate intravenously (IV) and undergo MRI scans prior to receiving standard-of-care (SOC) treatment and again at 4 weeks after starting SOC treatment. Participants may optionally undergo an additional HP 13C pyruvate MRI scan at 8 weeks after starting SOC treatment. Participants who have excellent response and deemed candidates for surgical resection may be switched to Cohort B. Participants also undergo CT and additional MRI scans throughout the study.
干预措施: Magnetic Resonance Imaging (MRI) (Procedure)
Cohort B (HP 13C pyruvate, MRI)
Participants with localized PDA who are deemed candidates for neoadjuvant therapy (NAT) receive HP 13C pyruvate IV and undergo MRI scans prior to starting NAT and again at 4 weeks after starting NAT. Participants may optionally undergo an additional HP 13C pyruvate MRI scan at 8 weeks after starting NAT. Participants who develop rapidly progressive disease and are deemed non-resectable may be switched to Cohort A. Participants also undergo CT and additional MRI scans throughout the study.
干预措施: Hyperpolarized 13C-Pyruvate (Drug)
Cohort B (HP 13C pyruvate, MRI)
Participants with localized PDA who are deemed candidates for neoadjuvant therapy (NAT) receive HP 13C pyruvate IV and undergo MRI scans prior to starting NAT and again at 4 weeks after starting NAT. Participants may optionally undergo an additional HP 13C pyruvate MRI scan at 8 weeks after starting NAT. Participants who develop rapidly progressive disease and are deemed non-resectable may be switched to Cohort A. Participants also undergo CT and additional MRI scans throughout the study.
干预措施: Computed tomography (CT) (Procedure)
Cohort B (HP 13C pyruvate, MRI)
Participants with localized PDA who are deemed candidates for neoadjuvant therapy (NAT) receive HP 13C pyruvate IV and undergo MRI scans prior to starting NAT and again at 4 weeks after starting NAT. Participants may optionally undergo an additional HP 13C pyruvate MRI scan at 8 weeks after starting NAT. Participants who develop rapidly progressive disease and are deemed non-resectable may be switched to Cohort A. Participants also undergo CT and additional MRI scans throughout the study.
干预措施: Magnetic Resonance Imaging (MRI) (Procedure)
结局指标
主要结局
Proportion of participants with best objective response (Cohorts A and B)
时间窗: Up to 24 months
The best objective response based on clinical imaging according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.11 will be reported
Mean percent change in target tumor peak HP 13C lactate/pyruvate ratio over time
时间窗: Up to 6 weeks
The mean percent change in peak HP 13C lactate/pyruvate ratio with 95% confidence intervals (CI) will be reported for scans completed at baseline and after 4 weeks (+/- 2 weeks) of non-interventional, standard of care treatment.
Mean change in target tumor HP 13C lactate/pyruvate area under the curve (AUC) ratio over time
时间窗: Up to 6 weeks
The mean change in HP 13C lactate/pyruvate area under the curve (AUC) ratio will be reported for scans completed at baseline and scans after 4 weeks (+/- 2 weeks) of non-interventional, standard of care treatment.
Mean percent change in target tumor HP 13C pyruvate to lactate conversion rate (kPL).
时间窗: Up to 6 weeks
The mean percent change in pyruvate to lactate conversion rate (kPL) will be reported for scans completed at baseline and scans after 4 weeks (+/- 2 weeks) of non-interventional, standard of care treatment.
次要结局
未报告次要终点
研究者
Zhen Wang, MD
Principal Investigator
University of California, San Francisco