临床试验/NCT01217385

NCT01217385已完成不适用

Diffuse Optical Spectroscopy Imaging in Monitoring and Predicting Response in Patients With Locally Advanced Breast Cancer Undergoing Chemotherapy Before Surgery

American College of Radiology Imaging Network2 个研究点分布在 1 个国家目标入组 60 人开始时间: 2011年6月1日最近更新: 2023年1月17日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: American College of Radiology Imaging Network
入组人数: 60
试验地点: 2
主要终点: Accuracy of %Change in TOI Between Baseline and Mid-therapy to Predict Pathologic Response (pCR +/-)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

RATIONALE: New imaging procedures, such as diffuse optical spectroscopy imaging, may help measure a patient's response and allow doctors to plan better treatment.

PURPOSE: This clinical trial studies diffuse optical spectroscopy imaging in monitoring and predicting response in patients with locally advanced breast cancer undergoing chemotherapy before surgery.

详细描述

OBJECTIVES:

Primary

To determine whether the percentage change in the diffuse optical spectroscopy imaging (DOSI) measurement of the tumor/normal (T/N) tissue optical index (TOI) from baseline to mid-therapy is predictive of the final pathologic response of the primary tumor in patients with locally advanced breast cancer treated with neoadjuvant chemotherapy.

Secondary

To investigate whether change of TOI measurements from baseline to post-therapy are predictive of the final pathologic response in these patients treated with this regimen.
To investigate whether baseline TOI measurements are associated with final pathologic response in patients treated with this regimen.
To investigate whether TOI measurements at baseline, change from baseline to mid-therapy, and change from baseline to post-therapy correlate with available MRI volumetric imaging measurements.
To investigate whether changes on TOI measurements from baseline to mid-therapy, and from baseline to post-therapy, correlate with other standard-of-care imaging and/or any MRI-imaging measurements.
To explore whether additional optical endpoints and indices obtained during DOSI measurements can be used to predict final pathologic response in patients treated with this regimen.
To determine a cutpoint for the percent change of TOI from baseline to mid-therapy that is predictive of pathological complete response in patients treated with this regimen.

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: Female
接受健康志愿者: 否

入选标准

•Pathologically confirmed diagnosis of invasive breast cancer, determined to be a candidate for primary systemic (neoadjuvant) therapy and for surgical resection of residual primary tumor following completion of neoadjuvant therapy;
•Tumor size >2cm, measured on imaging or estimated by physical exam;
•No contraindications for primary chemotherapy;
•Planned definitive breast surgery (mastectomy or lumpectomy/breast conservation) following completion of neoadjuvant therapy;
•Age 18 years or older;
•ECOG Performance Status ≤ 2 (Karnofsky ≥ 60%; see Appendix II);
•Normal organ and marrow function as follows:
•leukocytes ≥ 3,000/μl;
•absolute neutrophil count ≥ 1,500/μl;
•platelets ≥ 100,000/μl;
•total bilirubin within normal institutional limits;
•AST(SGOT)/ALT(SGPT) ≤ 2.5 times the institutional upper limit of normal;
•creatinine within normal institutional limits; OR
•creatinine clearance ≥ 30 mL/min/1.73 m2 for patients with creatinine levels above institutional normal;
•If female, postmenopausal for a minimum of one year, OR surgically sterile, OR not pregnant, confirmed by a pregnancy test as per institutional Standard of Care (SOC), and willing to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation;
•Able to understand and willing to sign a written informed consent document and a HIPAA authorization in accordance with institutional guidelines;

排除标准

•Previous treatment (chemotherapy, radiation, or surgery) to involved breast; including hormone therapy;
•Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements;
•Medically unstable;
•Under age 18;
•Pregnant or nursing;
•Previous malignancy, other than basal cell or squamous cell carcinoma of the skin or in situ carcinoma of the cervix, from which the patient has been disease free for less than 5 years.

研究组 & 干预措施

DOSI Pre-Surgery

Experimental

Participants undergo approximately four assessments of breast health using the DOSI technology during treatment and prior to surgery for breast cancer.

干预措施: DOSI (Procedure)

结局指标

主要结局

Accuracy of %Change in TOI Between Baseline and Mid-therapy to Predict Pathologic Response (pCR +/-)

时间窗: From baseline to mid-therapy

This measure will look at the Accuracy of % change in DOSI measured Tumor Optical Index (TOI) from baseline to mid therapy to predict pathologic response (pCR+ v pCR-) Pathologic response (dichotomized into responders (pCR+) and non-responders (pCR-) based pathologic assessment) will be used as the reference standard and Accuracy will be determined using receiver operating characteristic (ROC) analysis to determine the ROC Area Under the Curve (AUC).

次要结局

%Change in TOI Between Baseline and Mid-therapy to Predict pCR+; Stratified by Progesterone Receptor (PR) Status (Positive, Negative, Unknown )(baseline to mid-therapy)
Estimate the Optimal Cutpoint for %Change in TOI From Baseline to Mid-therapy to Predict pCR(baseline to mid-therapy)
Accuracy of %Change in TOI Between Baseline and Mid-therapy to Predict pCR+; Stratified by Oxygen Saturation (St02)(baseline to mid-therapy)

研究者

发起方

American College of Radiology Imaging Network

申办方类型

Network

责任方

Sponsor

研究点 (2)

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