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DNA Double-strand Breaks After SPECT

DNA Double-strand Breaks Following Myocardial Scintigraphy

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01380821
Acronym
DSB-SPECT
Enrollment
40
Registered
2011-06-27
Start date
2011-03-31
Completion date
2013-01-31
Last updated
2013-05-03

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

Conditions

Coronary Artery Disease

Keywords

clinical indication for myocardial SPECT, suspected or known coronary artery disease

Brief summary

Ionizing radiation has a number of harmful effects in humans. The most important among these is the induction of cancer. It is assumed that damage to DNA in the nucleus of a single cell can induce cancer. Among the different types of lesions inducted, DNA double-strand breaks (DSBs) are considered to be the most relevant effects that can initiate carcinogenesis. The investigators are already conducting several other studies to prospectively compare the inducted DSBs by coronary CT-angiography and conventional coronary angiography. Extending these examinations to investigate the induced DSBs by myocardial scintigraphy allows a comparison of all three relevant imaging methods of the heart that incorporate ionizing radiation. To evaluate this, the investigators are planning to examine patients who are scheduled for a clinically indicated myocardial scintigraphy. These examinations are routinely done by the Department of Nuclear Medicine in either a 1-day or a 2-day protocol according to the diagnostic reference values of the Federal Department for Radiological Protection. Blood samples will be taken from these patients at predefined time steps before and after the examination and DNA double-strand breaks will be determined from these blood samples specifically considering the applied activity of the tracer and the exposition kinetics.

Interventions

Myocardial SPECT according to clinical standards for patients with a clinical indication to undergo this imaging test.

Sponsors

Charite University, Berlin, Germany
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* myocardial SPECT clinically indicated

Exclusion criteria

* acute leukaemia or lymphoma * radiation or chemotherapy in the last 6 months * x-ray or scintigraphy within the last 3 days * age below 18 years * eGFR of below 60 ml/min

Design outcomes

Primary

MeasureTime frameDescription
Radiation-induced DNA double-strand breaks after myocardial scintigraphy.48 hoursDNA double-strand breaks will be measured before and up to 48 hours after radiation.

Secondary

MeasureTime frameDescription
Comparison of radiation-induced DSBs with activity used for myocardial scintigraphy.Activity will be measured 5 min and 1h after injection of the technetium tracer for SPECT.DNA double-strand breaks will be compared with injected activity.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026