title: Prospective trial with optical molecular imaging for percutaneous interventions in focal hepatic lesions.
abstract: OBJECTIVE
  To demonstrate the clinical translation of optical molecular imaging (OMI) for the localization of focal hepatic lesions during percutaneous hepatic interventions.
  
  
  METHODS
  Institutional review board approval was obtained for this prospective, single-center, HIPAA-compliant trial. Patients who were suspected of having hepatocellular carcinoma or liver metastases from colorectal cancer and were scheduled for percutaneous liver biopsy or thermal ablation were eligible for this study. Patients (n = 5) received 0.5 mg per kilogram of body weight of indocyanine green (ICG) intravenously 24 hours prior to their scheduled procedure in this study. Intraprocedurally, a handheld device composed of an endoscope that fits coaxially through a standard 17-gauge introducer needle was advanced into the liver, and real-time measurements of ICG fluorescence were obtained. A point-of-care fluorescence imaging system was used to image ICG fluorescence in biopsy samples. Target-to-background ratios (TBRs) were calculated by dividing the mean fluorescence intensity in the lesion by the mean fluorescence intensity in the adjacent liver parenchyma. The reference standard for determination of proper needle positioning in patients undergoing biopsy was final pathologic analysis of biopsy specimens or follow-up imaging.
  
  
  RESULTS
  Intraprocedural OMI was successfully performed in six lesions (two lesions in patient 3) in five patients. The median size of the targeted lesions was 16 mm (range, 10-21 mm). Four of five biopsies (80%) yielded an accurate pathologic diagnosis, and one biopsy specimen showed benign liver parenchyma; both ablated lesions showed no residual disease 1 month after the procedure. The median overall added procedure time to perform OMI was 2 minutes. ICG was found to localize with TBRs greater than 2.0 (median, 7.9; range, 2.4-13.4) in all target lesions. No trial-related adverse events were reported.
  
  
  CONCLUSIONS
  The clinical translation of OMI to percutaneous hepatic interventions was demonstrated.
authors.affiliation: From the Departments of Radiology (R.A.S., R.S.A., R.N.U., A.E.S., D.A.G., U.M.) and Hematology/Oncology (L.G., A.X.Z.), Massachusetts General Hospital, 149 13th St, Room 2301, Charlestown, MA 02129.
authors.forename: Rahul A
authors.initials: RA
authors.lastname: Sheth
authors.forename: Ronald S
authors.initials: RS
authors.lastname: Arellano
authors.forename: Raul N
authors.initials: RN
authors.lastname: Uppot
authors.forename: Anthony E
authors.initials: AE
authors.lastname: Samir
authors.forename: Lipika
authors.initials: L
authors.lastname: Goyal
authors.forename: Andrew X
authors.initials: AX
authors.lastname: Zhu
authors.forename: Debra A
authors.initials: DA
authors.lastname: Gervais
authors.forename: Umar
authors.initials: U
authors.lastname: Mahmood
mesh_terms: D000368:Aged; D004396:Coloring Agents; D006801:Humans; D007208:Indocyanine Green; D008107:Liver Diseases / Q000175:diagnosis* / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D057054:Molecular Imaging; D061848:Optical Imaging; D011446:Prospective Studies
chemical_list: D004396:Coloring Agents; D007208:Indocyanine Green