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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

Sponsor
Cem Ilgin Erol (Other)
Overall Status
Completed
CT.gov ID
NCT04882371
Collaborator
(none)
88
Enrollment
1
Location
31
Actual Duration (Months)
2.8
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • 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.

Study Design

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 :
Jan 1, 2018
Actual Primary Completion Date :
May 1, 2020
Actual Study Completion Date :
Aug 1, 2020

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Radiological evaluation of response to neoadjuvant chemotheraphy for breast cancer [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 [2 months]

    Surgery was performed for all patient after neoadjuvant chemotherapy. Pathological datas were analyzed

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Istanbul Medeniyet University Goztepe City Hospital Istanbul Kadikoy Turkey 34100

Sponsors and Collaborators

  • Cem Ilgin Erol

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Cem Ilgin Erol, MD, Istanbul Medeniyet University
ClinicalTrials.gov Identifier:
NCT04882371
Other Study ID Numbers:
  • 2020-0327
First Posted:
May 11, 2021
Last Update Posted:
May 11, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Cem Ilgin Erol, MD, Istanbul Medeniyet University
Breast Neoplasms
Neoadjuvant chemotherapy
RECIST
PERCIST
Additional relevant MeSH terms:
Breast Neoplasms

Study Results

No Results Posted as of May 11, 2021