NCT00605488已完成不适用
Pilot Study Investigating the Biodistribution and Potential Diagnostic Ability of 18F FACBC in Patients With Head and Neck, Breast, and Prostate Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- To study the biodistribution and dosimetry of FACBC in patients with head and neck squamous cell carcinoma (HNSCC), breast cancer and prostate cancer.
研究概览
简要总结
See where the dye-like material (FACBC) goes in your body and how long it stays in your body. See how much of the dye-like material is picked up by your tumor Compare the FACBC pictures with other pictures (such as FDG PET scan) that were obtained as part of your standard imaging evaluation.
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 ≥ or equal 18 years old
- •Scheduled for treatment at Memorial Hospital
- •Primary HNSCC or primary breast cancer; histological confirmation of diagnosis at Memorial hospital
- •Large primary HNSCC cancer (loco-regional advanced, ≥ or equal to T2) by CT/MRI imaging or clinical exam, without prior treatment, N1-N3
- •Large primary breast cancer (≥ or equal to T2) by imaging or clinical impression based physical exam; patients with suspicion of axillary nodal disease (N1-2), without prior treatment
- •Established progressive metastatic prostate cancer
- •This diagnosis may be based upon histologic confirmation of metastatic disease by biopsy of a lesion OR clear clinical evidence for metastatic disease (e.g., based on clinical findings, laboratory data and/or imaging findings in CT, MRI, or bone scan), as defined by the referring oncologist
- •Progressive disease is defined as clear progression on imaging studies (increase in size and number of lesions on bone scan, CT, or MRI) and consecutive rises in PSA as used in clinical management by the prostate cancer oncology group at MSKCC
- •FDG PET scan was obtained as part of the clinical work-up, within 4 weeks prior to enrollment. This clinical FDG PET scan should be done at MSKCC.
- •Disease can be clearly demonstrated by structural imaging (CT or MRI) or bone scan. This may include characteristic bone lesions on bone scan, CT or MRI; AND/OR measurable soft tissue/nodal lesions on CT or MRI.
- •Minimum tumor/metastasis size of 1 cm
- •Negative pregnancy test
排除标准
- •Patient cannot tolerate lying still for approximately 60 minute sessions in the PET tomograph.
- •Pregnancy
结局指标
主要结局
To study the biodistribution and dosimetry of FACBC in patients with head and neck squamous cell carcinoma (HNSCC), breast cancer and prostate cancer.
时间窗: conclusion of study
次要结局
- To compare these FACBC data with PET imaging findings using the current clinical standard PET tracer FDG.(conclusion of study)
研究者
研究点 (1)
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