Breast Neoplasm Malignant Breast Tissue Clinical Trial
Official title:
What Are the Factors Affecting Neoadjuvant Chemotherapy Efficacy in Breast Cancer? A Non-invasive in Vivo Study Using Specialist Magnetic Resonance (MR) Methods
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.
| Status | Recruiting |
| Enrollment | 25 |
| Est. completion date | June 2019 |
| Est. primary completion date | June 2019 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Patients with pathologically confirmed invasive breast cancer undergoing neoadjuvant chemotherapy and surgery. Exclusion Criteria: - 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. |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | NHS Grampian | Aberdeen | Aberdeenshire |
| Lead Sponsor | Collaborator |
|---|---|
| University of Aberdeen | NHS Grampian |
United Kingdom,
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* Note: There are 12 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Baseline: Water diffusion probability density function (Full-Width-At-Half-Maximum, FWHM, units of micrometre) | The water diffusion probability density function will be quantified by the Full-Width-At-Half-Maximum with units of micrometre | Scan at pre-treatment baseline (Prior to start of Cycle 1, each cycle is 21 days) | |
| Primary | Post Cycle 1: Water diffusion probability density function (Full-Width-At-Half-Maximum, FWHM, units of micrometre) | The water diffusion probability density function will be quantified by the Full-Width-At-Half-Maximum with units of micrometre | Scan at the end of Cycle 1 (Each cycle is 21 days) | |
| Primary | Post Cycle 3: Water diffusion probability density function (Full-Width-At-Half-Maximum, FWHM, units of micrometre) | The water diffusion probability density function will be quantified by the Full-Width-At-Half-Maximum with units of micrometre | Scan at the end of Cycle 3 (Each cycle is 21 days) | |
| Primary | Post Treatment: Water diffusion probability density function (Full-Width-At-Half-Maximum, FWHM, units of micrometre) | The water diffusion probability density function will be quantified by the Full-Width-At-Half-Maximum with units of micrometre | Scan at the end of Cycle 6 (Each cycle is 21 days) | |
| Primary | Baseline: Water diffusivity (units of mm^2 /s) | Water diffusivity with units of mm^2 /s | Scan at pre-treatment baseline (Prior to start of Cycle 1, each cycle is 21 days) | |
| Primary | Post Cycle 1: Water diffusivity (units of mm^2 /s) | Water diffusivity with units of mm^2 /s | Scan at the end of Cycle 1 (Each cycle is 21 days) | |
| Primary | Post Cycle 3: Water diffusivity (units of mm^2 /s) | Water diffusivity with units of mm^2 /s | Scan at the end of Cycle 3 (Each cycle is 21 days) | |
| Primary | Post Treatment: Water diffusivity (units of mm^2 /s) | Water diffusivity with units of mm^2 /s | Scan at the end of Cycle 6 (Each cycle is 21 days) | |
| Primary | Baseline: Lactate Concentration (units of mM) | Lactate concentration with units of mM | Scan at pre-treatment baseline (Prior to start of Cycle 1, each cycle is 21 days) | |
| Primary | Post Cycle 1: Lactate Concentration (units of mM) | Lactate concentration with units of mM | Scan at the end of Cycle 1 (Each cycle is 21 days) | |
| Primary | Post Cycle 3: Lactate Concentration (units of mM) | Lactate concentration with units of mM | Scan at the end of Cycle 3 (Each cycle is 21 days) | |
| Primary | Post Treatment: Lactate Concentration (units of mM) | Lactate concentration with units of mM | Scan at the end of Cycle 6 (Each cycle is 21 days) | |
| Primary | Baseline: Lipid Peak Volume Ratio (Ratio Units) | Lipid peak volume ratio value with units of ratio | Scan at pre-treatment baseline (Prior to start of Cycle 1, each cycle is 21 days) | |
| Primary | Post Cycle 1: Lipid Peak Volume Ratio (Ratio Units) | Lipid peak volume ratio value with units of ratio | Scan at the end of Cycle 1 (Each cycle is 21 days) | |
| Primary | Post Cycle 3: Lipid Peak Volume Ratio (Ratio Units) | Lipid peak volume ratio value with units of ratio | Scan at the end of Cycle 3 (Each cycle is 21 days) | |
| Primary | Post Treatment: Lipid Peak Volume Ratio (Ratio Units) | Lipid peak volume ratio value with units of ratio | Scan at the end of Cycle 6 (Each cycle is 21 days) | |
| Primary | Baseline: Fat Fraction (units of %) | Fat Fraction with units of % | Scan at pre-treatment baseline (Prior to start of Cycle 1, each cycle is 21 days) | |
| Primary | Post Cycle 1: Fat Fraction (units of %) | Fat Fraction with units of % | Scan at the end of Cycle 1 (Each cycle is 21 days) | |
| Primary | Post Cycle 3: Fat Fraction (units of %) | Fat Fraction with units of % | Scan at the end of Cycle 3 (Each cycle is 21 days) | |
| Primary | Post Treatment: Fat Fraction (units of %) | Fat Fraction with units of % | Scan at the end of Cycle 6 (Each cycle is 21 days) | |
| Secondary | Core Biopsy Tumour Tissue: Ki-67 Staining Percentage (units of %) | Ki-67 staining percentage with units of %, assessed on core biopsy tissue taken prior to start of treatment cycles. | 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. | |
| Secondary | Excised Tumour Tissue: Ki-67 Staining Percentage (units of %) | Ki-67 staining percentage with units of %, assessed on excised tissue taken from surgery following completion of treatment cycles. | Post-treatment surgery excision (Post Cycle 6, each cycle is 21 days). Assessed following the completion of routine pathological reporting of the excised tissue. | |
| Secondary | Core Biopsy Tumour Tissue: Serotonin Staining Score (arbitrary units) | Serotonin staining score with arbitrary units (multiplication of staining percentage and stain intensity scored 1 - 3), assessed on core biopsy tissue taken prior to start of treatment cycles. | 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. | |
| Secondary | Excised Tumour Tissue: Serotonin Staining Score (arbitrary units) | Serotonin staining score with arbitrary units (multiplication of staining percentage and stain intensity scored 1 - 3), assessed on excised tissue taken from surgery following completion of treatment cycles. | Post-treatment surgery excision (Post Cycle 6, each cycle is 21 days). Assessed following the completion of routine pathological reporting of the excised tissue. | |
| Secondary | Core Biopsy Tumour Tissue: Cellularity (units of %) | Cellularity with units of %, assessed on core biopsy taken prior to start of treatment cycles. | 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. | |
| Secondary | Excised Tumour Tissue: Cellularity (units of %) | Cellularity with units of %, assessed on excised tissue taken from surgery following completion of treatment cycles. | Post-treatment surgery excision (Post Cycle 6, each cycle is 21 days). Assessed following the completion of routine pathological reporting of the excised tissue. |