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

Breast Cancer Clinical Trial

Official title:

Added Value of Contrast Enhanced Spectral Mammography, CESM in Diagnostics and Size Estimation of Malignant Lesions in Breast. A Pilot Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03402529
• Other study ID #: 2017/505
• Status: Completed
• Phase: N/A
• Start date: November 28, 2017
• Est. completion date: October 19, 2018

Study information

• Verified date: January 2019
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: October 19, 2018
• Est. primary completion date: October 19, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Diagnostic Test:
• Contrast Enhanced Spectral Mammography
Pilot study

Locations

Country	Name	City	State
Sweden	Department of Surgery	Lund

Sponsors (1)

Lead Sponsor	Collaborator
Region Skane

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with change of treatment	Mastectomy instead of partial mastectomy, neo-adjuvant chemotherapy instead of primary surgery	1 month
Secondary	size assessment of malignant lesions	correlation with definitive PAD	2 months