Participant flow

OTL38 for Intra-operative Imaging of Folate Receptor Positive Ovarian Cancer · Source last updated 2022-02-04

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   Patient injected with OTL38 and undergoes near infrared imaging. Drug: OTL38 0.025 mg/kg of OTL38 in 250ml dextrose 5% in water (D5W) infused intravenously over 60 minutes Other Names: OTL38 for Injection Device: near infrared camera imaging system Infrared imaging used to excite OTL38 for fluorescence Other Names: Near IR imaging Procedure/Surgery: laparotomy primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery

   id

   FG000

   title

   Experimental: OTL38 Injection and Near Infrared Imaging

2. description

   Patient injected with OTL38, but does not undergo fluorescent imaging. Drug: OTL38 0.025 mg/kg of OTL38 in 250ml dextrose 5% in water (D5W) infused intravenously over 60 minutes Other Names: OTL38 for Injection Procedure/Surgery: laparotomy primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery

   id

   FG001

   title

   Sham Comparator: OTL38 Injection and No Fluorescent Imaging

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         0

      type

      Lost to Follow-up

   2. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Death

   3. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         0

      type

      Majority of which were disease too extensive and camera not used

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         134

      2. group Id

         FG001

         num Subjects

         6

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         134

      2. group Id

         FG001

         num Subjects

         16

      comment

      All subjects received study drug prior to randomization. A total of 150 subjects received study drug, 10 of which were not randomized to either arm. These 10 subjects withdrew to the study prior to randomization but are included in the Safety Analysis Set.

      type

      Safety Analysis Set

   3. achievements

      1. group Id

         FG000

         num Subjects

         134

      2. group Id

         FG001

         num Subjects

         0

      type

      Full Analysis Set/ Intent to Image Set

   4. achievements

      1. group Id

         FG000

         num Subjects

         106

      2. group Id

         FG001

         num Subjects

         0

      type

      Per Protocol Analysis Set

   5. achievements

      1. group Id

         FG000

         num Subjects

         122

      2. group Id

         FG001

         num Subjects

         6

      type

      Pharmacokinetic Analysis Set

   6. achievements

      1. group Id

         FG000

         num Subjects

         128

      2. group Id

         FG001

         num Subjects

         6

      type

      COMPLETED

   7. achievements

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         0

      type

      NOT COMPLETED

   title

   Overall Study

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice