Hodgkin Lymphoma Treated With Mediastinal Irradiation Clinical Trial
Official title:
Hybrid Single-Photon Emission Computed Tomography/Computed Tomography Coronary Angiography for the Assessment of the Presence and Hemodynamic Significance of CAD in Asymptomatic Patients After Mediastinal Irradiation for Hodgkin Lymphoma.
Mediastinal irradiation for treatment of malignancy increases the risk for coronary artery
disease (CAD), while diabetes mellitus or other known risk factors can be absent at the time
of the first coronary event. Radiation-induced atherosclerosis affects the coronary ostia
and proximal coronary segments, or causes diffuse microvascular damage. Younger patients and
those exposed to high radiation doses (> 35 Gy) have a higher risk for developing premature
CAD and likely may benefit from coronary assessment.
A novel hybrid imaging technique that combines SPECT and CTCA has been shown to overcome the
individual pitfalls and the diagnostic challenges of stand-alone SPECT and CCTA, improve the
lesion detectability and sensitivity in patients with balanced diffuse lesions as well as
the specificity and mainly PPV of CTCA.
The aim of the study is to perform hybrid SPECT/CTCA in asymptomatic patients with HL who
have received radiotherapy to the mediastinum in order to allow an early diagnosis of
hemodynamically significant CAD that will need further therapeutic interventions.
| Status | Not yet recruiting |
| Enrollment | 100 |
| Est. completion date | |
| Est. primary completion date | January 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - Asymptomatic HL patients without evidence of disease and without prior history of CAD that underwent mediastinal irradiation due to HL Exclusion Criteria: - Known CAD (these patients will be excluded from the imaging study, but will be analyzed as separate control group) - active HL or other active malignancy - chronic renal failure - pregnant/ nursing women - previous allergic reaction to iodine contrast media |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
| Country | Name | City | State |
|---|---|---|---|
| Israel | Rambam Healthcare Campus | Haifa |
| Lead Sponsor | Collaborator |
|---|---|
| Rambam Health Care Campus |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Extent of coronary artery plaques and number of perfusion defects in patients enrolled. | 12 months | No |