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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04882371
• Other study ID #: 2020-0327
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: August 1, 2020

Study information

• Verified date: May 2021
• Source: Istanbul Medeniyet University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: August 1, 2020
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Chemotherapy Effect

Intervention

Drug:
• Chemotherapy
Neoadjuvant Chemotherapy for Breast Cancer

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

Locations

Country	Name	City	State
Turkey	Istanbul Medeniyet University Goztepe City Hospital	Istanbul	Kadikoy

Sponsors (1)

Lead Sponsor	Collaborator
Cem Ilgin Erol

Country where clinical trial is conducted

Turkey, 

References & Publications (29)

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* Note: There are 29 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pathological evaluation of response to neoadjuvant chemotheraphy for breast cancer	Surgery was performed for all patient after neoadjuvant chemotherapy. Pathological datas were analyzed	2 months