Comparison of MRI With PET / CT in the Evaluation of Response to Neoadjuvant Therapy Based on the Molecular Subtypes of Breast Cancer

NCT04882371 | Completed

• 1 other identifier: 2020-0327
• Study Type: observational
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

The current study aims to determine the diagnostic accuracy of Magnetic Resonance Imaging (MRI) and Positron Emission Tomography- Computed Tomography (PET-CT) in predicting a pathological response of molecular subtypes of breast cancer to neoadjuvant chemotherapy (NAC).

Conditions

Breast Cancer; Chemotherapy Effect

Keywords

Breast Neoplasms; Neoadjuvant chemotherapy; RECIST; PERCIST

Outcome Measures

Primary Outcomes (1)

• Radiological evaluation of response to neoadjuvant chemotheraphy for breast cancer

  All patient had neoadjuvant chemotherapy, then a group of patient evaluated with MRI and the other group of patient with PET-CT

  2 months

Secondary Outcomes (1)

• Pathological evaluation of response to neoadjuvant chemotheraphy for breast cancer

  2 months

Study Arms (2)

MRI RECIST

Radiological responses were evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST) and changes in contrast enhancement patterns on MRI

Drug: Chemotherapy; Diagnostic Test: Magnetic Resonance Imaging (MRI)

PET-CT PERCIST

Radiological responses were evaluated according to the classification of PET Response Criteria in Solid Tumors (PERCIST) on PET-CT.

Drug: Chemotherapy; Diagnostic Test: Positron emission tomography - Copmputer Tomography (PET-CT)

Interventions

Chemotherapy DRUG

Neoadjuvant Chemotherapy for Breast Cancer

MRI RECIST; PET-CT PERCIST

Magnetic Resonance Imaging (MRI) DIAGNOSTIC_TEST

Performed contrasted MRI for evaluate response of neoadjuvant chemotherapy

MRI RECIST

Positron emission tomography - Copmputer Tomography (PET-CT) DIAGNOSTIC_TEST

Performed contrasted PET-CT for evaluate response of neoadjuvant chemotherapy

PET-CT PERCIST

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with breast cancer who had undergone surgery after neoadjuvant chemotherapy

You may qualify if:

• Older than 18
• Breast cancer patients
• Had neoadjuvant chemotherapy before surgery
• Had undergone surgery after chemotherapy

You may not qualify if:

• Younger than 18
• History of surgery for breast cancer

Sponsors & Collaborators

• Cem Ilgin Erol: lead

Study Sites (1)

Istanbul Medeniyet University Goztepe City Hospital

Istanbul, Kadikoy, 34100, Turkey (Türkiye)

Location

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MeSH Terms

Conditions

Breast Neoplasms

Interventions

Drug Therapy; Magnetic Resonance Imaging; Positron Emission Tomography Computed Tomography

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics; Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Positron-Emission Tomography; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Tomography, X-Ray Computed; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Radionuclide Imaging; Diagnostic Techniques, Radioisotope

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 8, 2021
• First Posted: May 11, 2021
• Study Start: January 1, 2018
• Primary Completion: May 1, 2020
• Study Completion: August 1, 2020
• Last Updated: May 11, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)