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

NCT00162045 ↗

Phase 1/2 Completed 79 enrolled Lantheus Medical Imaging

Non-randomizedSingle-groupOpen-labelDiagnostic

Summary

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.

Timeline

Start: 2005-01
Primary completion: 2007-05
Completion: 2007-06

Publications

Azarbar S, Salardini A, Dahdah N, Lazewatsky J, Sparks R, Portman M, Crane PD, Lee ML, Zhu Q. A Phase I-II, Open-Label, Multicenter Trial to Determine the Dosimetry and Safety of 99mTc-Sestamibi in Pediatric Subjects. J Nucl Med. 2015 May;56(5):728-36. doi: 10.2967/jnumed.114.146795. Epub 2015 Apr 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	TECHNETIUM SESTAMIBI	Diagnostic / imaging agent	3.7 mbq/kg	—
Subject	TECHNETIUM SESTAMIBI	Diagnostic / imaging agent	7.4 mbq/kg	—
Subject	TECHNETIUM SESTAMIBI	Diagnostic / imaging agent	11.1 mbq/kg	—

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

Summary

Timeline

Publications

Drugs

Indications