Feasibility of Biodynamic Imaging for Predicting Effect of Gemcitabine and Nab-paclitaxel on Metastatic Adenocarcinoma of the Pancreas
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- BDI as a chemosensitivity assay on fresh tumor samples
研究概览
简要总结
The purpose of this study is to determine if you can use an assay on tumor samples to see different patterns in response to the same chemotherapy treatment.
详细描述
To examine the feasibility of using biodynamic imaging (BDI) as a chemosensitivity assay on fresh tumor samples obtained by core needle biopsy from patients planned to receive routine care gemcitabine and nab-paclitaxel for treatment of metastatic adenocarcinoma of the pancreas.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Ability to understand and willingness to sign an informed consent and authorization for release of health information for research
- •≥ 18 years old at time of consent
- •Patients with a diagnosis of metastatic pancreatic cancer (mPC) who have not received prior combination chemotherapy. Exception: prior adjuvant chemoradiation with fluorouracil or gemcitabine is allowed.
- •Patients considered for routine care treatment with gemcitabine and nab-paclitaxel (allowed to receive other experimental therapy with gem/nab backbone if participating in another clinical trial)
- •Measurable disease by RECIST v1.1 criteria
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1
- •Willingness to undergo transcutaneous core needle biopsy of metastatic tumor for research purposes
- •Women are eligible to participate if they are of non-childbearing potential or have documentation of a negative pregnancy test (serum or urine β-hCG) within 1 week of the start of protocol treatment.
- •Women and men of childbearing potential must agree to use adequate, highly effective contraceptive measures during protocol treatment
- •Laboratory values: Platelets ≥ 100 K/mm3 international normalized ratio (INR) < 1.2, Partial thromboplastin time (PTT) in normal range, Cr < 2.0, Total bilirubin < 2 times upper limit normal (ULN), transaminases < 5 times ULN
排除标准
- •History of abnormal bleeding with minor procedures or documented platelet aggregation disorder such as VonWillebrand disease
- •Women who are pregnant or breastfeeding
结局指标
主要结局
BDI as a chemosensitivity assay on fresh tumor samples
时间窗: up to 336 days
To examine the feasibility of using BDI as a chemosensitivity assay on fresh tumor samples obtained by core needle biopsy from patients planned to receive routine care gemcitabine and nab-paclitaxel for treatment of metastatic adenocarcinoma of the pancreas.
次要结局
- BDI patterns and results with Response Evaluation Criteria(up to 336 days)
研究者
Patrick Joseph Loehrer Sr.
Professor
Indiana University