PMID- 16954550 OWN - NLM STAT- MEDLINE DCOM- 20061024 LR - 20191210 IS - 0161-5505 (Print) IS - 0161-5505 (Linking) VI - 47 IP - 9 DP - 2006 Sep TI - Integrin receptor imaging of breast cancer: a proof-of-concept study to evaluate 99mTc-NC100692. PG - 1434-9 AB - The present study was a proof-of-concept study to provide an initial indication of the efficacy and safety of imaging malignant breast tumors using (99m)Tc-NC100692. The agent is a small peptide with high affinity for integrin receptors that are upregulated and expressed preferentially on proliferating endothelial cells. METHODS: Sixteen patients with suggestive mammographic findings and 4 patients with benign lesions were included. The "standard of truth" was based on the histopathologic diagnosis of the recruited patients. All subjects received up to 75 microg of (99m)Tc-NC100692 with an average (99m)Tc activity of 694 MBq (range, 561-747 MBq). Safety endpoints were treatment-emergent adverse events (AEs) and changes in a limited physical examination, electrocardiogram (ECG) recordings, blood biochemistry, hematology, coagulation, vital signs, and urine analysis after administration of (99m)Tc-NC100692 and throughout the 24-h follow-up. Static images and SPECT were acquired between 40 min and 2.5 h after injection of the agent. Two experienced nuclear medicine physicians read the images in a nonblinded fashion. RESULTS: Nineteen of 22 malignant lesions were detected using (99m)Tc-NC100692 scintigraphy. Twenty lesions confirmed as malignant by histopathology were seen on mammography or ultrasound. Two additional lesions were identified from histopathology alone. Safety parameters evaluated through the follow-up period of 2.5 h included clinical laboratory tests, vital signs, and ECG. Five of 20 subjects experienced nonserious AEs, and all AEs were classified as mild. One subject experienced an AE (dysgeusia) possibly related to administration of (99m)Tc-NC100692. This AE was mild and lasted only for a few minutes. No deaths, serious AEs, or withdrawals due to AEs occurred during the study. CONCLUSION: Nineteen of 22 malignant lesions (86%) were clearly detected via scintigraphic imaging after administration of (99m)Tc-NC100692. Overall, the efficacy data in subjects with suspected breast lesions suggest that (99m)Tc-NC100692 scintigraphy may be effective in detecting malignant lesions. The use of (99m)Tc-NC100692 in subjects with breast cancer is safe and well tolerated. Further studies are warranted to assess the clinical potential of (99m)Tc-NC100692. FAU - Bach-Gansmo, Tore AU - Bach-Gansmo T AD - Rikshospitalet-Radiumhospitalet Medical Center, Oslo, Norway. tore.bach-gansmo@radiumhospitalet.no FAU - Danielsson, Rimma AU - Danielsson R FAU - Saracco, Ariel AU - Saracco A FAU - Wilczek, Brigitte AU - Wilczek B FAU - Bogsrud, Trond V AU - Bogsrud TV FAU - Fangberget, Anne AU - Fangberget A FAU - Tangerud, Ase AU - Tangerud A FAU - Tobin, Derek AU - Tobin D LA - eng PT - Evaluation Study PT - Journal Article PT - Research Support, Non-U.S. Gov't PL - United States TA - J Nucl Med JT - Journal of nuclear medicine : official publication, Society of Nuclear Medicine JID - 0217410 RN - 0 (Biomarkers, Tumor) RN - 0 (Integrin alphaVbeta3) RN - 0 (Neoplasm Proteins) RN - 0 (Organotechnetium Compounds) RN - 0 (Peptides, Cyclic) RN - 0 (Radiopharmaceuticals) RN - H0X34CV8RR (technetium 99m NC 100692) SB - IM EIN - J Nucl Med. 2007 Apr;48(4):567 MH - Adult MH - Aged MH - Biomarkers, Tumor/*metabolism MH - Breast Neoplasms/blood supply/*diagnostic imaging/*metabolism MH - Feasibility Studies MH - Female MH - Humans MH - Integrin alphaVbeta3/*metabolism MH - Middle Aged MH - Neoplasm Proteins/*metabolism MH - Neovascularization, Pathologic/diagnostic imaging/metabolism MH - Organotechnetium Compounds/*pharmacokinetics MH - Peptides, Cyclic/*pharmacokinetics MH - Pilot Projects MH - Radionuclide Imaging MH - Radiopharmaceuticals/pharmacokinetics MH - Reproducibility of Results MH - Sensitivity and Specificity EDAT- 2006/09/07 09:00 MHDA- 2006/10/25 09:00 CRDT- 2006/09/07 09:00 PHST- 2006/09/07 09:00 [pubmed] PHST- 2006/10/25 09:00 [medline] PHST- 2006/09/07 09:00 [entrez] AID - 47/9/1434 [pii] PST - ppublish SO - J Nucl Med. 2006 Sep;47(9):1434-9.