What Are the Factors Affecting Neoadjuvant Chemotherapy Efficacy in Breast Cancer? A Non-invasive in Vivo Study Using Specialist Magnetic Resonance (MR) Methods
试验速览
- 阶段
- 不适用
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Baseline: Water diffusion probability density function (Full-Width-At-Half-Maximum, FWHM, units of micrometre)
研究概览
简要总结
Breast cancer is the most prevalent cancer affecting women. To treat locally advanced breast cancers, neoadjuvant chemotherapy (NACT) is often carried out before surgery to reduce the tumour size to allow breast conservation surgery. However, treatment response for individual patients varies, where the tumour may not respond to treatment and the quality of patient care is compromised if the NACT treatment plan is not optimised. Therefore, the assessment of NACT efficacy is beneficial for the early identification of these patients and appropriate management of treatment.
Breast tumours have unique features compared to healthy tissue, including abnormal tissue structure and biochemical composition. With NACT there are specific changes to such tumour features indicating tumour treatment response.
The purpose of this study is to establish how the changes to breast tumour features following NACT treatment are seen in non-invasive imaging. This study will look at scans of breast tumours using magnetic resonance imaging (MRI). Changes to tissue structure will be measured by advanced diffusion MRI techniques and changes to tumour related biochemical substances will be measured by advanced magnetic resonance spectroscopy techniques. The investigators aim to assess if these techniques can provide information on the tumour treatment response following subsequent rounds of NACT treatment.
In this longitudinal study, 25 patients undergoing NACT will be recruited for four repeated MRI investigations over the course of NACT treatment. Magnetic resonance (MR) measurements of tissue microstructure and biochemical composition will be compared against histological measurements and radiological assessments of treatment response.
The study will recruit patients undergoing treatment at the NHS Grampian. This research is funded by Friends of ANCHOR, Tenovus Scotland Grampian and the NHS Grampian Endowment Research Fund.
详细描述
In this single group longitudinal study, the investigators propose that functional images from magnetic resonance (MR) methods performed at baseline and after 6 cycles of neoadjuvant chemotherapy (NACT) are in agreement with histological findings from pre-treatment biopsy and post-treatment surgically excised tissue. MR methods will be performed at baseline (pre-treatment) and after the 1st, 3rd and 6th (post-treatment) cycles of NACT treatment. The investigators hypothesise that specific physiological changes detected through MR methods are a manifestation of tumour response to NACT confirmed by histology and radiological assessment (Hypothesis 1). The investigators further hypothesise that early sensitivity to physiological changes manifesting from tumour response to NACT can be revealed by MR measurements after the first and third cycle of treatment (Hypothesis 2).
Research Question 1: Is there a difference in physiological parameters revealed by MR measurements at baseline and after completion of NACT?
Research Question 2: Do the physiological measurements at the completion of NACT from MR measures agree with histological findings?
Research Question 3: Is there a difference between MR measurements at baseline and after the first and third cycle of NACT?
Research Question 4: Is there a difference in MR measurements at baseline, first and third cycle of NACT, between positive treatment responders and non-responders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
Single group with one arm and no masking.
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
- •Patients with pathologically confirmed invasive breast cancer undergoing neoadjuvant chemotherapy and surgery.
排除标准
- •Condition to contradictive to MRI investigation with contrast agent (poor renal function, contrast agent allergy, metal implants or pace maker).
- •Started hormone or chemotherapy treatment before recruitment.
- •Undergoing treatment for concurrent cancer diagnosis.
- •Marker coil contradictive to MRI investigation.
研究组 & 干预措施
Single Arm
25 patients with pathologically confirmed invasive breast cancer who will undergo neoadjuvant chemotherapy treatment (NACT) and surgery will be recruited. During the study, patients will receive the standard care and the current study will not alter the care plan offered to them. All patients in the single arm will undergo 4 magnetic resonance imaging scan sessions. Histopathological analysis will be performed on the core biopsy and tumour tissue removed in surgery. Health questionnaire will be completed by each patient.
干预措施: Magnetic Resonance Imaging (Other)
Single Arm
25 patients with pathologically confirmed invasive breast cancer who will undergo neoadjuvant chemotherapy treatment (NACT) and surgery will be recruited. During the study, patients will receive the standard care and the current study will not alter the care plan offered to them. All patients in the single arm will undergo 4 magnetic resonance imaging scan sessions. Histopathological analysis will be performed on the core biopsy and tumour tissue removed in surgery. Health questionnaire will be completed by each patient.
干预措施: Histopathological Analysis (Other)
Single Arm
25 patients with pathologically confirmed invasive breast cancer who will undergo neoadjuvant chemotherapy treatment (NACT) and surgery will be recruited. During the study, patients will receive the standard care and the current study will not alter the care plan offered to them. All patients in the single arm will undergo 4 magnetic resonance imaging scan sessions. Histopathological analysis will be performed on the core biopsy and tumour tissue removed in surgery. Health questionnaire will be completed by each patient.
干预措施: Health Questionnaire (Other)
结局指标
主要结局
Baseline: Water diffusion probability density function (Full-Width-At-Half-Maximum, FWHM, units of micrometre)
时间窗: Scan at pre-treatment baseline (Prior to start of Cycle 1, each cycle is 21 days)
The water diffusion probability density function will be quantified by the Full-Width-At-Half-Maximum with units of micrometre
Post Cycle 1: Water diffusivity (units of mm^2 /s)
时间窗: Scan at the end of Cycle 1 (Each cycle is 21 days)
Water diffusivity with units of mm\^2 /s
Post Cycle 3: Water diffusivity (units of mm^2 /s)
时间窗: Scan at the end of Cycle 3 (Each cycle is 21 days)
Water diffusivity with units of mm\^2 /s
Baseline: Lactate Concentration (units of mM)
时间窗: Scan at pre-treatment baseline (Prior to start of Cycle 1, each cycle is 21 days)
Lactate concentration with units of mM
Baseline: Fat Fraction (units of %)
时间窗: Scan at pre-treatment baseline (Prior to start of Cycle 1, each cycle is 21 days)
Fat Fraction with units of %
Post Cycle 3: Lipid Peak Volume Ratio (Ratio Units)
时间窗: Scan at the end of Cycle 3 (Each cycle is 21 days)
Lipid peak volume ratio value with units of ratio
Post Treatment: Lipid Peak Volume Ratio (Ratio Units)
时间窗: Scan at the end of Cycle 6 (Each cycle is 21 days)
Lipid peak volume ratio value with units of ratio
Post Cycle 1: Water diffusion probability density function (Full-Width-At-Half-Maximum, FWHM, units of micrometre)
时间窗: Scan at the end of Cycle 1 (Each cycle is 21 days)
The water diffusion probability density function will be quantified by the Full-Width-At-Half-Maximum with units of micrometre
Post Cycle 3: Water diffusion probability density function (Full-Width-At-Half-Maximum, FWHM, units of micrometre)
时间窗: Scan at the end of Cycle 3 (Each cycle is 21 days)
The water diffusion probability density function will be quantified by the Full-Width-At-Half-Maximum with units of micrometre
Post Treatment: Water diffusion probability density function (Full-Width-At-Half-Maximum, FWHM, units of micrometre)
时间窗: Scan at the end of Cycle 6 (Each cycle is 21 days)
The water diffusion probability density function will be quantified by the Full-Width-At-Half-Maximum with units of micrometre
Baseline: Water diffusivity (units of mm^2 /s)
时间窗: Scan at pre-treatment baseline (Prior to start of Cycle 1, each cycle is 21 days)
Water diffusivity with units of mm\^2 /s
Post Treatment: Water diffusivity (units of mm^2 /s)
时间窗: Scan at the end of Cycle 6 (Each cycle is 21 days)
Water diffusivity with units of mm\^2 /s
Post Treatment: Lactate Concentration (units of mM)
时间窗: Scan at the end of Cycle 6 (Each cycle is 21 days)
Lactate concentration with units of mM
Post Cycle 1: Lipid Peak Volume Ratio (Ratio Units)
时间窗: Scan at the end of Cycle 1 (Each cycle is 21 days)
Lipid peak volume ratio value with units of ratio
Post Cycle 3: Fat Fraction (units of %)
时间窗: Scan at the end of Cycle 3 (Each cycle is 21 days)
Fat Fraction with units of %
Post Cycle 1: Lactate Concentration (units of mM)
时间窗: Scan at the end of Cycle 1 (Each cycle is 21 days)
Lactate concentration with units of mM
Post Cycle 3: Lactate Concentration (units of mM)
时间窗: Scan at the end of Cycle 3 (Each cycle is 21 days)
Lactate concentration with units of mM
Post Treatment: Fat Fraction (units of %)
时间窗: Scan at the end of Cycle 6 (Each cycle is 21 days)
Fat Fraction with units of %
Baseline: Lipid Peak Volume Ratio (Ratio Units)
时间窗: Scan at pre-treatment baseline (Prior to start of Cycle 1, each cycle is 21 days)
Lipid peak volume ratio value with units of ratio
Post Cycle 1: Fat Fraction (units of %)
时间窗: Scan at the end of Cycle 1 (Each cycle is 21 days)
Fat Fraction with units of %
次要结局
- Excised Tumour Tissue: Ki-67 Staining Percentage (units of %)(Post-treatment surgery excision (Post Cycle 6, each cycle is 21 days). Assessed following the completion of routine pathological reporting of the excised tissue.)
- Core Biopsy Tumour Tissue: Ki-67 Staining Percentage (units of %)(Pre-treatment baseline biopsy (Taken prior to start of Cycle 1, each cycle is 21 days). Assessed following completion of treatment cycles and the routine reporting of core biopsy and excised tissue samples.)
- Core Biopsy Tumour Tissue: Cellularity (units of %)(Pre-treatment baseline biopsy (Taken prior to start of Cycle 1, each cycle is 21 days). Assessed following completion of treatment cycles and the routine reporting of core biopsy and excised tissue samples.)
- Core Biopsy Tumour Tissue: Serotonin Staining Score (arbitrary units)(Pre-treatment baseline biopsy (Taken prior to start of Cycle 1, each cycle is 21 days). Assessed following completion of treatment cycles and the routine reporting of core biopsy and excised tissue samples.)
- Excised Tumour Tissue: Serotonin Staining Score (arbitrary units)(Post-treatment surgery excision (Post Cycle 6, each cycle is 21 days). Assessed following the completion of routine pathological reporting of the excised tissue.)
- Excised Tumour Tissue: Cellularity (units of %)(Post-treatment surgery excision (Post Cycle 6, each cycle is 21 days). Assessed following the completion of routine pathological reporting of the excised tissue.)