NCT01966809 · BASELINE
Baseline characteristics
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- denoms
- counts
- group Id
- BG000
- value
- 1
- units
- Participants
- groups
- description
- Photofrin photodynamic therapy. Drug - 2.5 mg/kg, light - 240 mJ/cm2. Photofrin photodynamic therapy.: The subjects will receive a dose of 2.5 mg/kg of Photofrin intravenously 24 hours before planned surgical resection. Tumor resection will be carried out in the standard fashion in order to achieve the maximum tumor resection compatible with preservation of neurological function. After resection, Intralipid will be infused into the craniotomy and kept for approximately 45 min, while PDT will be performed. The illumination time will be calculated from the power density (mW) emitted by the laser and the radius (r) of the cavity to deliver a total light dose of 240 J/cm2 at a using the following formula: Treatment Time (sec) = Light dose (J/cm2) x Cavity surface (cm2) x 1000 Power density (mW) Cavity Surface (cm2) = 4 x 3.14 x r2 The optical fiber will be placed in the center of the surgical cavity and photoillumination will commence.
- id
- BG000
- title
- Photofrin Photodynamic Therapy.
- measures
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- title
- <=18 years
- measurements
- group Id
- BG000
- value
- 0
- title
- Between 18 and 65 years
- measurements
- group Id
- BG000
- value
- 1
- title
- >=65 years
- denoms
- counts
- group Id
- BG000
- value
- 1
- units
- Participants
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Age, Categorical
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 1
- title
- Female
- measurements
- group Id
- BG000
- value
- 0
- title
- Male
- denoms
- counts
- group Id
- BG000
- value
- 1
- units
- Participants
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- denoms
- counts
- group Id
- BG000
- value
- 0
- units
- Participants
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Race and Ethnicity were not collected from any participant.
- title
- Race and Ethnicity Not Collected
- unit Of Measure
- Participants
Complete source fields
- denoms
- counts
- group Id
- BG000
- value
- 1
- units
- Participants
- groups
- description
- Photofrin photodynamic therapy. Drug - 2.5 mg/kg, light - 240 mJ/cm2. Photofrin photodynamic therapy.: The subjects will receive a dose of 2.5 mg/kg of Photofrin intravenously 24 hours before planned surgical resection. Tumor resection will be carried out in the standard fashion in order to achieve the maximum tumor resection compatible with preservation of neurological function. After resection, Intralipid will be infused into the craniotomy and kept for approximately 45 min, while PDT will be performed. The illumination time will be calculated from the power density (mW) emitted by the laser and the radius (r) of the cavity to deliver a total light dose of 240 J/cm2 at a using the following formula: Treatment Time (sec) = Light dose (J/cm2) x Cavity surface (cm2) x 1000 Power density (mW) Cavity Surface (cm2) = 4 x 3.14 x r2 The optical fiber will be placed in the center of the surgical cavity and photoillumination will commence.
- id
- BG000
- title
- Photofrin Photodynamic Therapy.
- measures
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- title
- <=18 years
- measurements
- group Id
- BG000
- value
- 0
- title
- Between 18 and 65 years
- measurements
- group Id
- BG000
- value
- 1
- title
- >=65 years
- denoms
- counts
- group Id
- BG000
- value
- 1
- units
- Participants
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Age, Categorical
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 1
- title
- Female
- measurements
- group Id
- BG000
- value
- 0
- title
- Male
- denoms
- counts
- group Id
- BG000
- value
- 1
- units
- Participants
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- denoms
- counts
- group Id
- BG000
- value
- 0
- units
- Participants
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Race and Ethnicity were not collected from any participant.
- title
- Race and Ethnicity Not Collected
- unit Of Measure
- Participants
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