NCT00534274已完成不适用
Study of Positron Emission Tomography With 3'-Deoxy-3'-[18F] Fluoro-thymidine ([18F]-FLT) for the Evaluation of Response to Neoadjuvant Chemotherapy for Cancers of the Breast
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- UNICANCER
- 入组人数
- 97
- 试验地点
- 24
- 主要终点
- Intensity of tumor uptake of 3'-deoxy-3'-(18F) fluorothymidine (18F-FLT) determined visually and correlated with histological or surgical response according to Sataloff criteria
研究概览
简要总结
RATIONALE: Diagnostic procedures, such as positron emission tomography (PET) using 3'-deoxy-3'-(18F) fluorothymidine, may be effective in assessing the response to chemotherapy before surgery in treating locally advanced breast cancer.
PURPOSE: This clinical trial is studying how well positron emission tomography using 3'-deoxy-3'-(18F) fluorothymidine works in treating women with locally advanced cancer in one breast who are receiving chemotherapy.
详细描述
OBJECTIVES:
Primary
- Evaluate the efficacy of positron emission tomography (PET) utilizing 3'-deoxy-3'-(18F) fluorothymidine (^18F-FLT) to correctly identify response to neoadjuvant chemotherapy in women with locally advanced unilateral breast cancer.
- Correlate PET-^18F-FLT results with histological response.
Secondary
- Evaluate the correlation of early changes in tumor uptake of ^18F-FLT after the first course of chemotherapy with complete response after treatment completion.
- Evaluate the correlation of early changes in tumor uptake of ^18F-FLT with histologic response in biopsies obtained after 1 course of chemotherapy.
- Determine if the initial intensity of tumor uptake is a predictive value of response to chemotherapy.
- Determine if initial intensity of tumor uptake of ^18F-FLT varies according to histologic type of tumor, indices of proliferation, and tumor cellularity before therapy.
- Determine if the tumor uptake of ^18F-FLT during therapy varies according to histologic type of tumor, indices of proliferation, and tumor cellularity before therapy.
- Evaluate the role of TK1 on the kinetics of ^18 F-FLT.
- Analyze serum.
- Research biomarkers of genomics, transcription, and proteomics.
- Evaluate the toxicity of ^18F-FLT.
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 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Inclusion criteria:
- •Histologically confirmed unilateral breast cancer
- •T2 or T3, any N, M0
- •Unifocal by mammography and ultrasound
- •Negative for c-erbB2 by immunohistochemistry (IHC)
- •Planning neoadjuvant chemotherapy comprising anthracyclines and/or taxanes, alone or combined
- •Measurable disease by ultrasound
- •Hormone receptor status not specified
排除标准
- •Bilateral disease
- •Multifocal tumor
- •Invasive grade I lobular cancer
- •Metastatic disease
- •Stage ≥ T4 disease
- •Cutaneous invasion, major adherence, or inflammatory disease
- •Tumor overexpressing c-erbB2 by IHC (HER 2+++)
- •Suspected clinical or radiological lesion (examined or not)
- •PATIENT CHARACTERISTICS:
- •Inclusion criteria:
- •ECOG performance status 0-1
- •Menopausal status not specified
- •Hematologic, hepatic, and renal function normal
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •Exclusion criteria:
- •Alcohol dependency or prior reaction to ethanol injection
- •Impossible to receive study therapy due to geographical, social, or psychological reasons
- •Prisoners or patients under supervision
- •PRIOR CONCURRENT THERAPY:
- •Inclusion criteria:
- •See Disease Characteristics
- •Exclusion criteria:
- •Participation in another concurrent therapeutic study with an experimental drug
研究组 & 干预措施
TEP FLT
Experimental
干预措施: 3'-deoxy-3'-[18F]fluorothymidine (Other)
结局指标
主要结局
Intensity of tumor uptake of 3'-deoxy-3'-(18F) fluorothymidine (18F-FLT) determined visually and correlated with histological or surgical response according to Sataloff criteria
时间窗: Post surgery
次要结局
- Variation of tumoral uptake as seen by positron emission tomography (PET) before, during, and after therapy as determined visually and by SUV(Post surgery)
- Intensity of tumor uptake of 18F-FLT by standardized uptake value (SUV)(Post surgery)
- Intensity of the tumoral uptake of 18F-FLT on initial exam visually and by SUV(post surgery)
- Immunohistochemical evaluation (estrogen and progesterone receptors, c-erbB2, Ki-67, e-cadherin)(Post-surgery)
- Rate of thymidine kinase 1 (TK1)(Post surgery)
- Histologic parameters: type, grade, mitotic index, CCIS , and microbiopsy embols after first course of chemotherapy (and on microbiopsy before therapeutic change of sequence in patients receiving bisequential chemotherapy)(post surgery)
- Toxicity by CTC-AE v. 3.0(Post surgery)
研究者
研究点 (24)
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