cardiac damage cardiac sympathetic innervation injury
Conditions
Interventions
None listed
Sponsors
Medisch Centrum Haaglanden
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: -Histological confirmed adenocarcinoma of the left or right breast -Operable breast carcinoma (clinically T1-2; N0-1) -Breast conserving surgery (BCS) (and adequate axillary staging) -WHO performance: status * 2 - Patients participated in the calcium study [NL18534.098.07 / 07-090] - Written informed consent
Exclusion criteria
Exclusion criteria: -Histology other than adenocarcinoma -Distant metastases (including non-ipsilateral lymph node metastases) -"Locally advanced ("inoperable") breast cancer" (clinically T3-4; N2-3) -En bloc axillary dissection -Previous (non surgical) treatment of the breast carcinoma including pre-operative chemotherapy or hormonal therapy -Neurodegenerative diseases (Multiple systemic atrophy, central autonomic failure) - Parkinson's disease. -Male gender -Pregnancy Exclusion criteria for the MIBG scan: - Allergic to previous use of 123I-MIBG.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The assessment of the cardiac sympathetic system. This will be performed by using 123I-MIBG scintigraphy. The heart-to-mediastinum ratio (H/M ratio) and myocardial washout will be analysed for left- and right-sided breast cancer patients around three years after the radiotherapy treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| As a secundary endpoint the segmental distribution of the radiofarmacon in the heart will be analysed. Subjective findings in relation to the results of the MIBG scan of the heart will be described. | — |
Countries
Netherlands
Outcome results
None listed