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

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ClinicalTrials.gov Identifier: NCT04882371
Recruitment Status : Completed
First Posted : May 11, 2021
Last Update Posted : May 11, 2021
Sponsor:
Information provided by (Responsible Party):
Cem Ilgin Erol, Istanbul Medeniyet University

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).

Condition or disease Intervention/treatment
Breast Cancer Chemotherapy Effect Drug: Chemotherapy Diagnostic Test: Magnetic Resonance Imaging (MRI) Diagnostic Test: Positron emission tomography - Copmputer Tomography (PET-CT)

Detailed Description:
Eighty-eight patients with breast cancer who had undergone surgery after NAC were retrospectively analyzed between January 2018 and May 2020, at the general surgery clinic of Istanbul Medeniyet University Göztepe Training and Research Hospital. Demographic data, clinical findings, tumor markers, radiologic findings and pathology data were documented. With the use of MRI and / or PET-CT obtained before and after NAC, tumor staging was performed, and tumor size and the presence of metastatic lymph nodes and radiological response to NAC were evaluated. The response to NAC was evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST) and contrast enhancement patterns described by Tozaki et al. on MRI, and the classification PET Response Criteria in Solid Tumors (PERCIST) on PET-CT. The postoperative pathology study reported the followings: the size and histopathologic type of the tumor, its hormone receptor status, staining intensities (Allred score), HER-2 positivity, Ki-67 proliferation percentages, and the molecular subtypes; the presence and number of metastatic lymph nodes, the response of the tumor and, the metastatic lymph node, if any, to NAC according to the Sataloff classification. Patients with a Sataloff score of "A" were considered to have a pCR, those with the scores of "B" or "C" were considered to have a partial response. When examining the Sataloff scores, the presence of pCR in both the primary tumor and axilla was evaluated and compared with the presence of radiological complete response on MRI and / or PET-CT. In addition, the sensitivities of MRI and PET-CT in predicting pCR in patients undergoing NAC were statistically compared based on the molecular subtypes. Patients whose MRI and PET-CT findings were consistent with histopathologic data were included in the "Radiology-Pathology agreement " group. The sensitivity of imaging methods was determined by examining the rates of agreement in the molecular subgroups. The Statistical Package for Social Sciences software for Windows version 20 (SPSS Inc.; Chicago, IL, USA) was used for all analyses. Normality was assessed by the Shapiro-Wilk test. Categorical variables were compared using chi-square or, where appropriate, Fisher's exact test. The Mc-Nemar test was used for paired categorical data. Trends in tables larger than 2x2 were examined with the linear-by-linear association test. Kruskal-Wallis test was used to compare non-normal distributed variables in three groups. Cohen's kappa (κ) was calculated to test the agreement between the classifications of radiology and pathology.

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Study Type : Observational
Actual Enrollment : 88 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Comparison of MRI With PET / CT in the Evaluation of Response to Neoadjuvant Therapy Based on the Molecular Subtypes of Breast Cancer
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : May 1, 2020
Actual Study Completion Date : August 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort Intervention/treatment
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
Neoadjuvant Chemotherapy for Breast Cancer

Diagnostic Test: Magnetic Resonance Imaging (MRI)
Performed contrasted MRI for evaluate response of neoadjuvant chemotherapy

PET-CT PERCIST
Radiological responses were evaluated according to the classification of PET Response Criteria in Solid Tumors (PERCIST) on PET-CT.
Drug: Chemotherapy
Neoadjuvant Chemotherapy for Breast Cancer

Diagnostic Test: Positron emission tomography - Copmputer Tomography (PET-CT)
Performed contrasted PET-CT for evaluate response of neoadjuvant chemotherapy




Primary Outcome Measures :
  1. Radiological evaluation of response to neoadjuvant chemotheraphy for breast cancer [ Time Frame: 2 months ]
    All patient had neoadjuvant chemotherapy, then a group of patient evaluated with MRI and the other group of patient with PET-CT


Secondary Outcome Measures :
  1. Pathological evaluation of response to neoadjuvant chemotheraphy for breast cancer [ Time Frame: 2 months ]
    Surgery was performed for all patient after neoadjuvant chemotherapy. Pathological datas were analyzed



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with breast cancer who had undergone surgery after neoadjuvant chemotherapy
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Younger than 18
  • History of surgery for breast cancer

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04882371


Locations
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Turkey
Istanbul Medeniyet University Goztepe City Hospital
Istanbul, Kadikoy, Turkey, 34100
Sponsors and Collaborators
Cem Ilgin Erol
Publications:
World Health Organization, Fact Sheets, Detail, Cancer. https://www.who.int/news-room/fact-sheets/detail/cancer
International Agency for Research on Cancer, Globocan 2018 Report. https://www.uicc.org/news/global-cancer-data-globocan-2018

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Responsible Party: Cem Ilgin Erol, MD, Istanbul Medeniyet University
ClinicalTrials.gov Identifier: NCT04882371    
Other Study ID Numbers: 2020-0327
First Posted: May 11, 2021    Key Record Dates
Last Update Posted: May 11, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cem Ilgin Erol, Istanbul Medeniyet University:
Breast Neoplasms
Neoadjuvant chemotherapy
RECIST
PERCIST
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases