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Added Value of Contrast Enhanced Spectral Mammography, CESM. A Pilot Study.

NCT03402529 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2019-01-18

No results posted yet for this study

Summary

Introduction: To avoid unnecessary mastectomies and reoperations a correct size assessment of malignant lesions in breast is required. Sometimes a supplementary MRI is therefore recommended. However, at our unit MRI is not easily available. Contrast enhanced spectral mammography (CESM) has in smaller studies been shown to be equal to MRI regarding sensitivity and specificity. Size assessment using contrast-based modalities as CESM has also been shown to be significantly more accurate than using mammography. Prospective randomized studies using CESM are lacking.

Aim: The aim of the study is to evaluate the added value of CESM in diagnostics of breast cancer and choice of operation; partial mastectomy or mastectomy.

A pilot study of 50 patients will be conducted to prepare for a larger prospective randomized study.

Method: Patients found with breast cancer after diagnostics with mammography, ultrasound and core biopsy, and whom are recommended primary surgery, will be enrolled in the study. A supplementary examination with CESM will be performed. Preoperative extent of the malignant lesions are estimated with each modality and is later compared with the extent measured in post-operative PAD. Data on weight, length, age at menopaus, use of contraceptive pills, HRT or endocrine therapy, breast volume and density is collected, as well as data of diagnosis (ductal or lobular carcinoma), surrounding DCIS, histological grade, ER, PgR, Her2 expression and Ki67 index.

In this pilot study sensitivity and specificity for each modality is calculated. Multivariate analysis will be performed regarding influential factors. Pearson correlation coefficient will be calculated for each modality regarding size assessment of the malignant lesions in comparison with definitive PAD.

Conditions

Interventions

DIAGNOSTIC_TEST

Contrast Enhanced Spectral Mammography

Pilot study

Sponsors & Collaborators

  • Region Skane

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-28
Primary Completion
2018-10-19
Completion
2018-10-19

Countries

  • Sweden

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03402529 on ClinicalTrials.gov