[Assessment of clinical utility of 111In-DTPA-IgG scintigraphy in the detection of inflammation/infection--a report of multicenter phase II clinical trials].
A Phase II clinical study was performed in patients with strongly suspected focal sites of inflammation/infection to investigate clinical utility of 111In-DTPA-IgG. Neither adverse effects nor abnormal laboratory changes were noted in the all cases. Out of 59 patients, the clinical utility was evaluated in 56 patients with a total of 67 suspicious sites (19 in thorax, 13 in abdomen and pelvis, 30 in musculoskeletal system, and 5 in other regions). True positive results were obtained in 100% of lesions in the thorax (13/13) and the musculoskeletal system (26/26). There were three false negative and five false positive results. Overall sensitivity and specificity was 94.0% and 70.6%, respectively. Most of the true positive scintigram with the best image quality was acquired at Day 1 or Day 2 post-injection. A dose of 80 MBq was considered to be a practical dose for imaging. Our study indicates that 111In-DTPA-IgG is a safe and promising imaging agent for the detection of inflammation/infection, and that it is reasonable to proceed with Phase III studies to further evaluate clinical utility of the agent.
Kubo
A
A
Department of Radiology, School of Medicine, Keio University, Japan.
Oyama
K
K
Suzuki
K
K
Itoh
K
K
Endo
K
K
Uno
K
K
Mashima
Y
Y
Gotoh
H
H
Shimada
K
K
D000328:Adult; D000368:Aged; D005260:Female; D006801:Humans; D007074:Immunoglobulin G; D007205:Indium Radioisotopes; D007239:Infections / Q000000981:diagnostic imaging*; D007249:Inflammation / Q000000981:diagnostic imaging*; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D004369:Pentetic Acid / Q000031:analogs & derivatives*; D011877:Radionuclide Imaging; D014057:Tomography, X-Ray Computed
C069971:DTPA-IgG complex; D007074:Immunoglobulin G; D007205:Indium Radioisotopes; D004369:Pentetic Acid