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

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Diagnostic Test: Contrast Enhanced Spectral Mammography

• Registration Number: NCT03402529
• Lead Sponsor: Region Skane

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-28
• Study First Submitted: 2017-12-04
• Study First Submitted QC: 2018-01-17
• Study First Posted: 2018-01-18
• Primary Completion: 2018-10-19
• Study Completion: 2018-10-19
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-17
• Last Update Posted: 2019-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 47

Inclusion Criteria

• Patients diagnosed with breast cancer and whom are planned for primary surgery
• Signed informed consent

Exclusion Criteria

• Ongoing pregnancy
• Ongoing lactation
• Allergy against iodine contrast
• Treatment with metformin (against diabetes)
• Renal failure
• Hyperthyroidism
• Severe heart condition
• Myasthenia gravis
• Implants
• Inability to understand study information

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CESM	Contrast Enhanced Spectral Mammography	-

Primary Outcome Measures

Name	Time	Method
Number of participants with change of treatment	1 month	Mastectomy instead of partial mastectomy, neo-adjuvant chemotherapy instead of primary surgery

Secondary Outcome Measures

Name	Time	Method
size assessment of malignant lesions	2 months	correlation with definitive PAD

Trial Locations

Locations (1)

Department of Surgery; 🇸🇪 Lund, Sweden