DETection of Early Radiation-induced Myocardial Injury using cardiac sympathetic inNErvation scintigraphy (DETERMINE)
- Conditions
- cardiac damagecardiac sympathetic innervation injury1001108210006291
- Registration Number
- NL-OMON38745
- Lead Sponsor
- Medisch Centrum Haaglanden
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 41
-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
-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.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The assessment of the cardiac sympathetic system. This will be performed by<br /><br>using 123I-MIBG scintigraphy. The heart-to-mediastinum ratio (H/M ratio) and<br /><br>myocardial washout will be analysed for left- and right-sided breast cancer<br /><br>patients around three years after the radiotherapy treatment.</p><br>
- Secondary Outcome Measures
Name Time Method <p>As a secundary endpoint the segmental distribution of the radiofarmacon in the<br /><br>heart will be analysed.<br /><br>Subjective findings in relation to the results of the MIBG scan of the heart<br /><br>will be described.</p><br>