NCI 8701: A Pilot Study Utilizing C11 Alpha Methyl Tryptophan (AMT) PET Functional Imaging in Patients With Metastatic Invasive Breast Cancer Treated With 1 Methyl D Tryptophan Plus the Ad p53 DC Vaccine
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Occurrence of Detected Changes in Regions of Interest (ROIs)
研究概览
简要总结
The purpose of this research project is to create images of where and how the amino acid (the building blocks of proteins)Tryptophan is processed in normal and abnormal tissue in the patient's body. Tryptophan is a normal building block of proteins in the body. Sometimes in the case of cancer and other diseases, Tryptophan is processed abnormally, and possible treatments for this abnormality are of great interest because of the potential to improve cancer care.
详细描述
Coordinating Center: Southeast Phase 2 Consortium (SEP2C), Moffitt Cancer Center.
Research participation involves up to three experimental imaging examination visits in radiology: a baseline before the patient starts a cancer treatment, a follow-up a few days later, and a later follow up to see how the treatment may affect normal or abnormal processing of Tryptophan.
The research imaging results will be linked with other evidence of the patient's disease, but will not effect their care.
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
- •Patients must be enrolled on the NCI 8461/MCC 16025 study.
- •Consent for participation in this companion imaging study and be able to successfully complete a minimum of two AMT PET/CT scans.
排除标准
- •Patients must not meet any of the exclusion criteria for the NCI 8461/ MCC 16025 study.
- •Not have any medical conditions prohibiting the successful completion of a minimum of two AMT PET/CT scans.
研究组 & 干预措施
Radiotherapy
AMT positron emission tomography with integrated computed tomography (PET/CT)scanning in metastatic breast cancer patients to identify tumors with increased AMT uptake due to up-regulated IDO expression.
干预措施: Adenovirus-p53 transduced dendritic cell vaccine (Biological)
Radiotherapy
AMT positron emission tomography with integrated computed tomography (PET/CT)scanning in metastatic breast cancer patients to identify tumors with increased AMT uptake due to up-regulated IDO expression.
干预措施: 1-methyl-D-tryptophan (Drug)
Radiotherapy
AMT positron emission tomography with integrated computed tomography (PET/CT)scanning in metastatic breast cancer patients to identify tumors with increased AMT uptake due to up-regulated IDO expression.
干预措施: Carbon C 11 alpha-methyltryptophan (Radiation)
结局指标
主要结局
Occurrence of Detected Changes in Regions of Interest (ROIs)
时间窗: Average of 7 weeks
Changes in C-11 AMT uptake and localization (measured by SUV) between baseline and approximately 4 days after initiation of treatment. The primary objective is to determine whether such changes can be detected in regions of interest (ROIs) using PET/CT imaging in patients with metastatic breast cancer enrolled in NCI 8461/ MCC16025. The SUV values in identified regions of interest (ROIs) for each patient will be compared over time between baseline and approximately 4 days after initiation of treatment, and after completion of the protocol treatment. The analysis will be largely exploratory and descriptive as the sample size and study design will likely preclude an adequate/definitive statistical conclusion of SUV values between the two time points.
次要结局
- Number of Participants with Presence of IDO ImmunoHistoChemistry (IHC) Expression(Average of 7 weeks)
- Number of Participants with Immune Response(Average of 7 weeks)
- Number of Participants with Adverse Events(Average of 7 weeks)
- Number of Participants with Clinical Response(Average of 7 weeks)