ISSN 2326-7267
International Journal of Pharmacy and Pharmacology ISSN: 2326-7267 Vol. 2 (9), pp. 001-010, September, 2011. © International Scholars Journals
Full Length Research Paper
Clinical evaluation of 99mTc -2IT-INH in normal subjects and patients with tubercular lesions
Namrata Singh1,2* and Aseem Bhatnagar1
1Institute of Nuclear Medicine and Allied Sciences, New Delhi - 110054, India.
2Ambedkar Center for Biomedical Research, University of Delhi, Delhi - 110007, India.
Accepted 11 March, 2011
Abstract
99mTc-INH of high labeling efficiency and stability has been developed using indirect method. In vitro studies and animal experiments indicated its advantages as a specific tuberculosis imaging agent. The objective of this study was to establish the efficacy of 99mTc-INH in humans with sensitive as well as resistant tuberculosis by conducting a phase I clinical trial. The biodistribution studies were done in normal subjects and phase I clinical trial was conducted in 20 patients. Whole body scan and spots were acquired at 1 and 4 h. Angiography, blood pool and 24 h spot images of the lesion bearing areas were also acquired. The biodistribution suggested absence of in vivo breakdown of radiotracer, with main excretory pathways being hepatobiliary and renal. The biodistribution of 99mTc-INH was similar to the unlabeled INH reported earlier. Out of 20 patients, 13 patients with sensitive tubercular lesions in the lungs or bone and 2 patients with resistant tubercular lesion in lungs concentrated the 99mTc-INH while in the other 5 cases with old healed lesions no concentration of 99mTc-INH was observed in scintigraphy. An unsuspected bony lesion was discovered in a patient with known pulmonary disease. Bone lesions were visualized within 1 h while pulmonary lesions accumulated 99mTc-INH very slowly with time and 24 h acquisition appeared essential for the diagnostic interpretation. No adverse reaction was observed in the patients post injection. 99mTc-INH developed is safe for human use and has potential to qualify as a specific tuberculosis imaging radiopharmaceutical.
Key words: Isoniazid (INH), 99mTc, scintigraphy, clinical trials, radiopharmaceutical.