Participant flow

Investigation of Novel Surgical Imaging for Tumor Excision · Source last updated 2023-08-24

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

groups

1. description

   The LUM Imaging Device was used to examine inside the lumpectomy cavity to determine if the dye indicated any areas that might contain residual tumor. If the imaging tested positive for the cancer cells remaining in the lumpectomy cavity, the surgeon would remove an additional piece of tissue. This process was continued until a negative reading from the device was obtained or a maximum of 2 shaves of additional tissue had been removed. Patients in this arm received the study drug, LUM015. Study Device Arm: LUM015 was administered 2 to 6 hours prior to surgery. The LUM Imaging device was used to assist in the removal of additional tumor tissue.

   id

   FG000

   title

   Device Intervention: Lum Imaging Device Used During Surgery

2. description

   The LUM Imaging Device was not used to guide additional tissue removal. Patients in this arm received the study drug, LUM015.

   id

   FG001

   title

   Standard of Care Arm

3. description

   All the patients injected with LUM015 but withdrawn before randomization after standard of care.

   id

   FG002

   title

   Withdrawn Before Randomization

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         7

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         1

      type

      Physician Decision

   3. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         4

      type

      Protocol Violation

   4. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         2

      type

      Device issue

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         357

      2. group Id

         FG001

         num Subjects

         35

      3. group Id

         FG002

         num Subjects

         14

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         356

      2. group Id

         FG001

         num Subjects

         35

      3. group Id

         FG002

         num Subjects

         0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         14

      type

      NOT COMPLETED

   title

   Overall Study

recruitment Details

406 injected with LUM015 (LUMISIGHT), 14 withdrawn before randomization.

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Preserved source evidence · Not medical advice