We will investigate if irradiation of part of the heart leads to cardiac sympathetic innervation injury and subsequently to radiation induced cardiovascular disease.
ID
Source
Brief title
Condition
- Coronary artery disorders
- Breast neoplasms malignant and unspecified (incl nipple)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Radiotherapy is an independent risk factor for cardiovascular disease in cancer
patients. Modern radiotherapy techniques minimize the volume of the heart and
major coronary vessels exposed to high radiation doses. Still, some exposure is
often not avoidable. Radiation-induced heart disease is caused primarily by
inflammatory changes in the microvasculature ultimately leading to perfusion
defects and focal ischemia.
Radiation-induced heart disease can be diagnosed non-invasively by myocardial
perfusion scintigraphy to assess regional perfusion, wall motion and ejection
fraction or by computer tomography to assess the coronary arteries and or
calcium burden.
In many clinical circumstances, no structural heart disease can be shown by
traditional myocardial perfusion scintigraphy or coronary angiography
investigations. There is strong evidence that cardiac adrenergic innervation is
affected in very early stage of coronary artery disease in asymptomatic
subjects. In addition, assessment of cardiac sympathetic activity has important
prognostic and therapeutic implications in patients with heart disease.
In different cardiovascular diseases, there is growing evidence that, the
damage to cardiac sympathetic innervation can precede the alteration in
myocardial perfusion. Cardiac sympathetic innervation imaging using
123Iodine-Meta-Iodobenzyl-Guanidine (123I-MIBG) cardiac scintigraphy is one of
the few valid techniques available to evaluate sympathetic cardiac diseases. We
intend to study the effect of radiotherapy on the cardiac sympathetic
innervations using 123I-MIBG cardiac scintigraphy in breast cancer patients
about 3 years after radiotherapy.
Study objective
We will investigate if irradiation of part of the heart leads to cardiac
sympathetic innervation injury and subsequently to radiation induced
cardiovascular disease.
Study design
The cardiac sympathetic function was measured using 123I-MIBG scintigraphy. The
cohort consists of breast cancer patients (n=41) treated for whole breast
irradiation after (left and right sided) breast conserving surgery in which the
degree of vascular damage (CAC -CT) was assessed until three years after
radiotherapy.
Study burden and risks
- The Effective Dose Equivalent (EDE) of the total body, as a result of the
administered activity of 185 MBq, accounts 3.3mSv.
- Participating to the study will cost the patient 9 hours (including
travelling to the specific hospitals)
- If pathology was found in the MIBG scan, action will be taken by the study
coordinators
- The results of the study could be of benefit for patients with breast cancer
Lijnbaan 32
Den Haag 2512VA
NL
Lijnbaan 32
Den Haag 2512VA
NL
Listed location countries
Age
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
-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
Recruitment
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL46465.098.13 |