The Prognostic Value of FDG PET/CT and Diffusion-weighed Imaging on Breast Cancer

NCT ID: NCT01942759

Last Updated: 2014-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

43 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-06-30

Brief Summary

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The purpose of this study is to determine findings of positron emission tomography and diffusion weighted magnetic resonance in primary lesion and axillary metastasis of breast cancer and compare of two imaging modality in these patients.

Detailed Description

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We aimed that to correlate both primary lesion 18F-fluorodeoxyglucose (FDG) maximum standardized uptake value (SUVmax) and diffusion-weighted imaging (DWI) apparent diffusion coefficient (ADC) with clinicopathological prognostic factors and compare the prognostic value of these indexes in breast cancer in this study. The evaluated and compared parameters are SUVmax and ADC according to age, tumour size, lymph node metastasis, receptor status, histologic grade, modified Nottingham prognostic index.

Conditions

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Breast Neoplasms

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Histologic grade

According to the modified criteria of Bloom and Richardson grading system: grade 1, 2 and 3

No interventions assigned to this group

Axillary metastasis

Group A: axillary lymph node metastasis Group B: no axillary lymphatic metastasis

No interventions assigned to this group

Modified Nottingham prognostic index

NPI = pathological tumour size (cm) × 0.2 + lymph node stage (1, 2 or 3) + histological grade (1, 2 or 3)

The cut-off points of the index were 3.4 and 5.4 to divide patients into the good (≤3.4), moderate (3.41-5.4) and poor (\>5.4) prognostic groups

No interventions assigned to this group

Oestrogen receptor status

Negative Positive

No interventions assigned to this group

Progesterone receptor status

Negative Positive

No interventions assigned to this group

HER-2 neu status

Negative Positive

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Newly diagnosis of breast cancer for which surgical intervention is planned

Exclusion Criteria

* patients received neoadjuvant chemotherapy
* before breast surgery
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Bagcilar Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Aynur Ozen

Aynur Ozen

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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AYNUR OZEN, MD

Role: STUDY_CHAIR

Bagcilar Training & Research Hospital

Locations

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Bagcilar Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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BC-PET-MR-01

Identifier Type: -

Identifier Source: org_study_id

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