Preoperative prediction of axillary lymph node burden in early-stage invasive breast cancer
| ISRCTN | ISRCTN37165899 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN37165899 |
| Secondary identifying numbers | Chang Gung Memorial Hospital funding number: CMRPG6N0071 |
- Submission date
- 22/06/2024
- Registration date
- 26/06/2024
- Last edited
- 26/06/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
This study aims to use radiomics features extracted from preoperative breast MRI combining clinical and histological features to construct a prediction model for evaluating axillary lymph node (ALN) metastasis burden in patients with early-stage (T1-2) breast cancer. The study methodology provides a noninvasive and practical way of preoperatively predicting the extent of ALN involvement in early-stage (T1-2) breast cancer patients. It has the potential to tailor appropriate axillary treatment options for patients with early-stage breast cancer towards less invasive surgical practices.
Who can participate?
Patients aged 18 to 85 years old with early-stage invasive breast cancer
What does the study involve?
This study will look back through a database to find breast MRI images that fit specific criteria. People whose MRI scans are selected will be included in the study without needing to give consent again. They will have had a pre-scheduled breast MRI with a special contrast dye before any surgery, and no other tests will be required. The study will follow these participants from the time their images are taken until the study ends.
The goal is to create and test a model that can predict certain outcomes. Eighty patients with early-stage breast cancer will be included, with 56 in the training group and 24 in the testing group. The study will analyze features from their MRI images using a semi-automated process and consider their clinical and pathological information. A predictive model will be built using a machine learning technique called support vector machines.
What are the possible benefits and risks of participating?
The benefits include early prediction of axillary lymph node involvement, noninvasive assessment, personalized treatment planning and contribution to research.
The risks include data privacy concerns, inconvenience, potential for false positives/negatives and unknown long-term implications.
Where is the study run from?
Chang Gung Memorial Hospital Chiayi Branch, Taiwan
When is the study starting and how long is it expected to run for?
March 2023 to May 2024
Who is funding the study?
Chang Gung Memorial Hospital, Taiwan
Who is the main contact?
Shu-Tian Chen, stchen0909@gmail.com
Contact information
Public, Scientific, Principal Investigator
No.6, Sec West, Chia-Pu Rd. Putz
Chiayi
61363
Taiwan
 ORCID ID |
0000-0003-2650-3338 |
|---|---|
| Phone | +886 053621000 |
| sugarcan99@cgmh.org.tw |
Study information
| Study design | Single-center retrospective study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Medical and other records |
| Study type | Diagnostic |
| Participant information sheet | No participant information sheet available |
| Scientific title | Preoperative prediction of axillary lymph node burden in early-stage invasive breast cancer with clinical-pathology and MRI-based radiomics |
| Study objectives | Using radiomics features extracted from preoperative breast MRI combining clinicohistologic features may help to preoperatively predict axillary lymph node burden on breast cancer patients. |
| Ethics approval(s) |
Approved 28/03/2023, Chang Gung Medical Foundation Human Experiment Ethics Committee (199, Tung Hwa North Road, Taipei, 105, Taiwan; +886 (03) 3196200; Irb1@cgmh.org.tw), ref: 202201772B0C501 |
| Health condition(s) or problem(s) studied | Early stage breast cancer patients |
| Intervention | This study will retrospectively search a database to identify breast MRI images that meet specific inclusion and exclusion criteria. Owners of the selected breast MRI scans will be enrolled in the study with informed consent waived. Participants will undergo scheduled pre-operative staging dynamic contrast-enhanced breast MRI, with no additional studies required. The observation and follow-up periods will extend from the time of image acquisition until the conclusion of the study. The study aims to develop and validate a predictive model by enrolling eighty patients with early-stage breast cancer, divided into a training set (56 patients) and a validation set (24 patients). Radiomics features will be extracted from dynamic contrast-enhanced MRI images after semiautomated segmentation, and clinical-pathologic features will also be considered. Binary radiomics prediction models will be built using a support vector machines classifier. |
| Intervention type | Other |
| Primary outcome measure | Axillary lymph node burden prediction measured using the model prediction and MRI pathology reports after the axillary surgery at one timepoint |
| Secondary outcome measures | Performance comparison measures using the prediction model and by a radiologist after the axillary surgery at one timepoint |
| Overall study start date | 28/03/2023 |
| Completion date | 31/05/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 85 Years |
| Sex | Female |
| Target number of participants | 200 |
| Total final enrolment | 80 |
| Key inclusion criteria | 1. Invasive breast carcinoma confirmed by biopsy 2. Early-stage (clinical stage T1-2) 3. Underwent DCE-MRI examination one week before surgery 4. All patients who received axillary surgery either SLNB or ALND |
| Key exclusion criteria | 1. Non-primary breast cancer or carcinoma in situ-only lesions 2. Excision biopsy before DCE-MRI examination 3. Pre-operative neoadjuvant therapy 4. Incomplete clinical data |
| Date of first enrolment | 01/05/2023 |
| Date of final enrolment | 30/04/2024 |
Locations
Countries of recruitment
- Taiwan
Study participating centre
Chiayi County
61363
Taiwan
Sponsor information
Hospital/treatment centre
No.6, Sec West, Chia-Pu Rd. Putz
Chiayi
61363
Taiwan
| Phone | +886 053621000 |
|---|---|
| isc@cgmh.org.tw | |
| Website | https://www.cgmh.org.tw/branch/branch_jia.htm |
"ROR" |
https://ror.org/04gy6pv35 |
Funders
Funder type
Hospital/treatment centre
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Chia-Yi Chang-Gong Memorial Hospital, Chang Gung Memorial Hospital, Chia-Yi
- Location
- Taiwan
Results and Publications
| Intention to publish date | 30/05/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The data sharing plans for current study are unknown and will be made available at a later date. |
Editorial Notes
24/06/2024: Study's existence confirmed by the Chang Gung Medical Foundation Human Experiment Ethics Committee.
