The Prediction Model of NAC Response for Breast Cancer Based on The Parametric Dynamics Features.

NCT06370234 | Completed

• 1 other identifier: 201412166MINA
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

The main purpose of this study is to develop a computer-aided prediction model for NAC treatment response. Based on the heterogeneity of internal parametric tumor composition commonly observed, this study will utilize the histologic characteristics and treatment response to investigate the image features as input data for predicting treatment response using Deep Learning technology. Using this technique, preoperative treatment evaluation may be facilitated by tumor heterogeneity analysis from developed dynamic radiomics, and the possibility of personal medicine can be realized not far ahead. In the first two years of this study using images from DCE-MRI, PET/CT and QDS-IR, we plan to develop the image processing algorithms, including segmenting breast and tumor region, extracting image feature which reflects angiogenic properties and permeability of tumor, which are highly correlated with NAC treatment response. During the third year of the project, the morphology and texture features from first two years can be combined for PET/MRI and prediction model can be achieved in accordance with the features extracted from dynamic features extraction using longitudinal images of PET/MRI.

Conditions

Breast Cancer; Chemotherapy Effect; Diffusion Weighted MRI; PET Imaging; Multiparametric Magnetic Resonance Imaging

Keywords

Parametric imaging; Breast Cancer, Neoadjuvant Chemotherapy; Prediction Model; MR/PET; QDS-IR

Outcome Measures

Primary Outcomes (2)

• Model Prediction power of pathological complete response(pCR)

  Comparison of different of prediction models derived from MR/PET and QDS-IR in terms of AUCs.

  an average of four months

• Comparison of models in prediction of pathological complete response(pCR)

  Comparison of different of prediction models derived from MR/PET and QDS-IR in terms of sensitivity, specificity and accuracy.

  an average of four months

Study Arms (1)

PET/MR scanning for neoadjuvant chemotherapy breast cancer patients

OTHER

From April 2015 to June 2019, women with breast cancer who underwent neoadjuvant chemotherapy were enrolled. Arranged for at least three PET/MR scans during NAC: the first \[R0\], pre-treatment; and the second\[R1\], after two cycles of chemotherapy (post-treatment) and the third \[R2\] before surgery.

Radiation: Whole body 18F-FDG Positron Emission Tomography

Interventions

Whole body 18F-FDG Positron Emission Tomography RADIATION

The subjects enrolling and participating this study will have done PET/MR during pre-operation chemotherapy. But, in normal procedure, they will not have done.

PET/MR scanning for neoadjuvant chemotherapy breast cancer patients

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (a) were \> 20 years of age,
• (b) with pathologically confirmed breast cancer with core needle biopsy
• (c) were willing to undergo NAC
• (d) were eligible for surgery after NAC
• (e) were willing to undergo at least three PET/MR scans during NAC: the first \[R0\], pre-treatment; and the second \[R1\], after two cycles of chemotherapy (post-treatment) and before surgery \[R2\]

You may not qualify if:

• (a) distant metastases or recurrent breast cancer.
• (b) unable to comply with sequential PET/MR scanning schedule.
• (c) Impaired renal function, CCR\>30ml/min.
• (d) Known aller

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• Ministry of Science and Technology, Taiwan: collaborator

Related Publications (16)

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MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Yeun-Chung Chang, M.D., PhD.

  National Taiwan University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2016
• First Posted: April 17, 2024
• Study Start: April 21, 2015
• Primary Completion: June 30, 2019
• Study Completion: March 3, 2020
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share