Functional MRI in Predicting Response to Chemotherapy

NCT03969524 | Unknown

• 1 other identifier: MRI in response assesment
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

• Address the accuracy of functional MRI techniques to predict response to neoadjuvant chemotherapy given to local advanced breast cancer patients with correlation with pathology thus allowing early chemotherapy regimen modification to increase number of patients achieving pathological complete response or save patients from toxic effects of ineffective chemotherapy.

Conditions

Breast Cancer Patients

Outcome Measures

Primary Outcomes (2)

• correlations coefficient between functional techniques of MRI breast and histology

  by appropriate statistical test

  3 years

• changes in the different functional technique's parameters according to the type of response.

  by appropriate statistical test

  3 years

Interventions

MRI DEVICE

Patients will undergo magnetic resonance imaging (MRI) at baseline (T0) (before NAC) and after the 2nd cycle of neoadjuvant chemotherapy(T2). Histopathological examination (gold standard) of the surgical specimen will be done for each patient and Compared to the results of MRI.

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

Selection of patients diagnosed with of biopsy proven breast cancer (BIRAD VI ) :

You may qualify if:

• patient in different age groups with local advanced breast cancer who are eligible for neoadjuvant chemotherapy and breast conservative surgery and in need for clip placement for tumor localization

You may not qualify if:

• Patient with breast cancer who are not eligible for NAC (pregnant patients, multicentric breast cancer, metastatic breast cancer).
• Patients who have received any prior chemotherapy, radiation therapy or tamoxifen therapy for their current breast cancer
• Patients with any general contraindication to MRI as presence of any paramagnetic substance as pacemakers, or those with claustrophobia.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

AssiutU

Asyut, 711111, Egypt

RECRUITING

Related Publications (2)

• Rieber A, Brambs HJ, Gabelmann A, Heilmann V, Kreienberg R, Kuhn T. Breast MRI for monitoring response of primary breast cancer to neo-adjuvant chemotherapy. Eur Radiol. 2002 Jul;12(7):1711-9. doi: 10.1007/s00330-001-1233-x. Epub 2002 Feb 14.

  PMID: 12111062 BACKGROUND

• Taourel P, Pages E, Millet I, Bourgier C, Rouanet P, Jacot W, Crochet P, Azria D. Magnetic resonance imaging in breast cancer management in the context of neo-adjuvant chemotherapy. Crit Rev Oncol Hematol. 2018 Dec;132:51-65. doi: 10.1016/j.critrevonc.2018.09.012. Epub 2018 Sep 25.

  PMID: 30447927 BACKGROUND

Study Officials

• Osama HA El-Sayed, Professor

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Heba AS Sabet, Msc

CONTACT

01000870587; bobaez1989@gmail.com

Marwa MS Mohamed, MD

CONTACT

01025260404; marwasamy2014@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of Radiology

Study Record Dates

• First Submitted: May 28, 2019
• First Posted: May 31, 2019
• Study Start: June 15, 2019
• Primary Completion: June 15, 2023
• Study Completion: December 30, 2023
• Last Updated: December 29, 2020

Record last verified: 2020-12

Locations

EG (1)