title: Photodynamic diagnosis with 5-aminolevulinic acid for intraoperative detection of peritoneal metastases of ovarian cancer: A feasibility and dose finding study.
abstract: With a prospective feasibility study, we aimed to analyse the effect of different time points for application and dosage of preoperative oral 5-aminolevulinic acid administration for photodynamic diagnosis of peritoneal metastases in ovarian cancer patients.
  
  
  
  In this prospective cohort study patients were randomly divided into three different groups. 5-Aminolevulinic acid was orally administered 3-14 hours before surgery using a dosage of 1 mg/kg, 4-9 hours using 10 mg/kg, and 9-16 hours using 10 mg/kg, respectively. Fluorescence was recorded intraoperatively using endoscopic equipment. The number and localization, of fluorescing nodules were documented. To analyze sensitivity and specificity samples from fluorescent and non-fluorescent tissues were evaluated histologically. Plasma protoporphyrin concentrations as well as any adverse events were assessed perioperatively.
  
  
  
  In total, 26 patients suspected for ovarian cancer underwent intraoperative photodynamic diagnosis with 5-aminolevulinic acid. Most of them suffered from advanced cancer, 72% from FIGO-Stage IIIc. No severe adverse events were observed. Orally applied 5-aminolevulinic acid with a dosage of 1 mg/kg revealed no detectable fluorescence. However, at a dosage of 10 mg/kg fluorescence of metastatic tissue was significantly stronger than of non-affected tissue. If administered 4-9 hours preoperatively best detection rates for peritoneal metastases were obtained resulting in a sensitivity of 75% and a specificity of 100%.
  
  
  
  Photodynamic diagnosis with 5-aminolevulinic acid leads to safe and specific fluorescence detection of peritoneal metastases. 5-Aminolevulinic acid should be used at a dosage of at least 10 mg/kg 4-9 hours preoperatively. Further phase I-II studies are recommended. Lasers Surg. Med. 49:169-176, 2017. © 2016 Wiley Periodicals, Inc.
authors.affiliation: Department of Obstetrics and Gynecology, Ludwig-Maximilians-University Hospital, Munich, Germany.|Department of Obstetrics and Gynecology, Hannover Medical School, Hannover, Germany.
authors.forename: Peter
authors.initials: P
authors.lastname: Hillemanns
authors.affiliation: Department of Obstetrics and Gynecology, Ludwig-Maximilians-University Hospital, Munich, Germany.|Department of Gynecology and Obstetrics, Technische Universität Dresden, Dresden, Germany.
authors.forename: Pauline
authors.initials: P
authors.lastname: Wimberger
authors.affiliation: Department of Obstetrics and Gynecology, Ludwig-Maximilians-University Hospital, Munich, Germany.|Department of Obstetrics and Gynecology, Klinikum Starnberg, Starnberg, Germany.
authors.forename: Jessica
authors.initials: J
authors.lastname: Reif
authors.affiliation: LIFE-Center, Hospital of the University of Munich, Munich, Germany.
authors.forename: Herbert
authors.initials: H
authors.lastname: Stepp
authors.affiliation: Department of Obstetrics and Gynecology, Hannover Medical School, Hannover, Germany.
authors.forename: Rüdiger
authors.initials: R
authors.lastname: Klapdor
mesh_terms: D000328:Adult; D000368:Aged; D000622:Aminolevulinic Acid / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008875:Middle Aged; D009367:Neoplasm Staging; D010051:Ovarian Neoplasms / Q000473:pathology* / Q000601:surgery; D010534:Peritoneal Neoplasms / Q000175:diagnosis* / Q000556:secondary*; D010778:Photochemotherapy; D017319:Photosensitizing Agents / Q000008:administration & dosage*; D011446:Prospective Studies; D012680:Sensitivity and Specificity
chemical_list: D017319:Photosensitizing Agents; D000622:Aminolevulinic Acid
keywords: 5-ALA; PDD; peritoneal carcinomatosis; residual disease