Skip to main content
OpenTrials
Completed

NCT Number: NCT01380821

DNA Double-strand Breaks After SPECT

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Charité

Berlin, State of Berlin, 10117, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Myocardial SPECT

Radiation

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

Primary outcomes

  1. Radiation-induced DNA double-strand breaks after myocardial scintigraphy.

    Time frame: 48 hours

    DNA double-strand breaks will be measured before and up to 48 hours after radiation.

Secondary outcomes

  1. Comparison of radiation-induced DSBs with activity used for myocardial scintigraphy.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

DNA Double-strand Breaks Following Myocardial Scintigraphy

Acronym: DSB-SPECT

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jun 27, 2011
Registry last updated
May 3, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.