Shear Wave Elastography Assessment of Neoadjuvant Chemotherapy Response in Patients With Invasive Breast Cancer

NCT05068999 | Unknown

• 1 other identifier: elastography in breast cancer
• Study Type: observational
• Target: 35
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study is to investigate the role of shear wave elastography (SWE) for early assessment of response to neoadjuvant chemotherapy in patients with invasive breast cancer.

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (1)

• shear wave elastography assessment in patients with invasive breast cancer.

  measurement of shear wave elastography parameters in patients with invasive breast cancer before and after neoadjuvant chemotherapy and assess the residual cancer burden for each patient.

  from october 2021 to october2022

Interventions

shear wave elastography DEVICE

Shear wave elastography (SWE) is an emerging technology that provides information about the inherent elasticity of tissues by producing an acoustic radiofrequency force impulse, sometimes called an "acoustic wind," which generates transversely-oriented shear waves that propagate through the surrounding tissue and provide biomechanical information about tissue quality. Although SWE has the potential to revolutionize bone and joint imaging, its clinical application has been hindered by technical and artifactual challenges. Many of the stumbling blocks encountered during musculoskeletal SWE imaging are readily recognizable and can be overcome, but progressive advances in technology and a better understanding of image acquisition are required before SWE can reliably be used in musculoskeletal imaging.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with breast cancer

You may qualify if:

• Histologically confirmed infiltrating breast cancer
• Stage II or stage III disease. Nodal status must be examined by ultrasound, fine needle aspiration, sentinel node biopsy, or FDG-PET scan.
• Age ≥18
• Eastern Cooperative Oncology Group performance status ≤1
• Adequate bone marrow function (ANC \>1.5 x 109/l, platelets \>100 x 109/l)
• Adequate hepatic function (ALAT, ASAT and bilirubin \<2.5 times upper limit of normal)
• Adequate renal function (creatinine clearance \>50 ml/min)
• LVEF ≥50% measured by echocardiography or MUGA
• Absence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
• Absence of any medical condition that would place the patient at unusual risk.
• Signed written informed consent

You may not qualify if:

• previous radiation therapy or chemotherapy
• Other malignancy except carcinoma in situ, unless the other malignancy was treated ≥5 years ago with curative intent without the use of chemotherapy or radiation therapy.
• Current pregnancy or breastfeeding. Women of childbearing potential must use adequate contraceptive protection.
• Evidence of distant metastases. Evaluation of the presence of distant metastases may include chest X-ray, liver ultrasound, isotope bone-scan, CT-scan of chest and abdomen and/or FDG-PET scan, according to local procedures.
• Evidence of bilateral infiltrating breast cancer. Evaluation of the presence of bilateral infiltrating breast cancer may include mammography, breast ultrasound and/or MRI breast.
• Concurrent anti-cancer treatment or another investigational drug.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (32)

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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

Central Study Contacts

rehab awad mohamed ahmed

CONTACT

01011511722; rehabawad740@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: September 25, 2021
• First Posted: October 6, 2021
• Study Start: December 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: March 1, 2023
• Last Updated: December 29, 2021

Record last verified: 2021-10