title: Clinical Evaluation of Efficacy of (99m)TC -Ethambutol in Tubercular Lesion Imaging.
abstract: Purpose. The aim of this work was to develop specific radiopharmaceutical and to evaluate its efficacy in human to detect and locate the tubercular lesion. Materials and Methods. (99m)Tc-Ethambutol (EMB) was produced by direct labeling method. In vitro and in vivo biological studies and animal experiments were done. Phase I Clinical trial was performed. As per plan, 2 normal human subjects for biodistribution studies and fourteen patients (8 males and 6 females; age range of 25-50, with one patient aged 12 years as an exception) were chosen for clinical trial. Whole body scan and spots were acquired at 1 hour and 4 hour. Angiography, blood pool, and 24-hours spot images of the infected areas were also acquired. Result. Radiolabeling yielded >85% of labeled complex. In vitro and in vivo biological studies and animal experiments indicated (99m)Tc-EMB as a specific tuberculosis imaging agent. The biodistribution study in normal human subjects suggested stability of (99m)Tc-EMB, with main excretory pathways being renal and hepatobiliary, which appeared to be similar to the known behavior of unlabeled EMB. No adverse reactions were observed. (99m)Tc-EMB got localized in pulmonary and bone tubercular lesions. Scintigrams of (99m)Tc-EMB and (99m)Tc-Ciprofloxacin were compared at different time intervals. Conclusion. The present study states that developed (99m)Tc-EMB has high potential to qualify as a specific tuberculosis imaging radiopharmaceutical and is safe for human use.
authors.affiliation: Department of Nuclear Medicine, Institute of Nuclear Medicine & Allied Sciences (INMAS), Brig. S.K. Mazumdar Marg Timarpur, New Delhi 1100054, India.
authors.forename: Namrata
authors.initials: N
authors.lastname: Singh
authors.forename: A
authors.initials: A
authors.lastname: Bhatnagar