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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03402529
Enrollment
47
Registered
2018-01-18
Start date
2017-11-28
Completion date
2018-10-19
Last updated
2019-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Contrast Enhanced Spectral Mammography

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.

Interventions

DIAGNOSTIC_TESTContrast Enhanced Spectral Mammography

Pilot study

Sponsors

Region Skane
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of participants with change of treatment1 monthMastectomy instead of partial mastectomy, neo-adjuvant chemotherapy instead of primary surgery

Secondary

MeasureTime frameDescription
size assessment of malignant lesions2 monthscorrelation with definitive PAD

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026