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Completed

NCT Number: NCT00162045

A Trial to Determine Radiation Exposure to Organs and Assess the Safety of CARDIOLITE® in Pediatric Subjects

The purpose of this Phase I-II multicenter clinical trial is to establish dosimetry and safety profiles for CARDIOLITE® (Technetium Tc99m Sestamibi) in pediatric subjects.

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Key information

Conditions

Kawasaki Disease Cardiovascular Diseases Hemic and Lymphatic Diseases Lymphatic Diseases Mucocutaneous Lymph Node Syndrome Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Vascular Diseases Vasculitis

Age range

4 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Local Institution, Vancouver, British Columbia, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Have been scheduled to undergo a clinically indicated rest or stress CARDIOLITE® MPI scan.
  • Be able to comply with imaging requirements permitting completion of rest or stress CARDIOLITE® whole-body scans and SPECT imaging procedures without the use of sedation.

Exclusion criteria

  • Have a terminal illness where expected survival is ≤6 months
  • Have known clinically significant laboratory abnormalities (creatine, liver enzymes, platelet count).

Treatment and study plan

Technetium Tc99m Sestamibi

Drug

Rest and/or stress SPECT imaging study

Primary outcomes

  1. Determination of the absorbed radiation dose of Sestamibi in subjects will be evaluated at the end of the study through measurements of PK (blood and urine) up to 8 hours, dosimetry for 8 hours and image biodistribution for up to 8 hours

    Time frame: Following administration of Technetium Tc99m Sestamibi

Secondary outcomes

  1. A determination of the safety of Sestamibi will be evaluated at the end of the study through adverse and serious adverse events reported and evaluating vital signs, ECGs, physical exams and laboratory tests for each subject

    Time frame: Following administration of Technetium Tc99m Sestamibi

Sponsors and collaborators

Lead sponsor

Lantheus Medical Imaging

Industry

Registry information

Official study title

A Phase I-II, Open-Label, Multicenter Trial to Determine the Dosimetry and Safety of Technetium Tc99m Sestamibi in Pediatric Subjects

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Sep 13, 2005
Registry last updated
Jun 2, 2011

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.

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