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Table 1 Number of patients and other study characteristics, by study

From: Diagnostic effectiveness of quantitative [18F]flutemetamol PET imaging for detection of fibrillar amyloid β using cortical biopsy histopathology as the standard of truth in subjects with idiopathic normal pressure hydrocephalus

 

Study A (Retrospective, US)

Study B (Prospective, US)

Study C (Retrospective, EU)

Study D (Prospective, EU)

N

7

11

15

17

Hospital setting

University of Pennsylvania Philadelphia, PA, USA

Johns Hopkins University Baltimore, MD, USA

• University of Eastern Finland Kuopio, Finland

4 neurosurgical units in Finland:

• Same 2 centers as in Study C

• Turku University Turku, Finland

• Helsinki University (Helsinki)

• Seinajoki Central Hospital (Seinajoki)

Patients

Retrospectively identified from database.

Patients scheduled for shunt placement were contacted.

Patients had previously undergone ICP monitoring and R frontal brain biopsy for suspected iNPH.

Patients scheduled for shunt placement were contacted.

Clinical conduct start/end dates

21 Dec 2009

11 Mar 2010

15 Jun 2010

31 May 2010

02 Jul 2010

05 Jan 2011

17 Nov 2010

16 Dec 2010

Order and timing of Biopsy/PET a,b

Biopsy/PET, 3 to 45 months apart

PET/Biopsy, approximately 8 weeks apart

Biopsy/PET, 8.8 to 38.2 months apart

PET/Biopsy, approximately 3 weeks apart

Diagnostic criteria for iNPH

Patients who had undergone shunting with concomitant R prefrontal cortical biopsy (most patients from a previous study of the impact of AD pathology on clinical response to shunting [18]).

Patients scheduled for shunt placement for iNPH.

Patients had previously undergone 24-hour ICP monitoring and R frontal cortical biopsy.

CT/MRI findings (enlarged ventricles + obliterated cortical sulci) + at least 2 of the 3 cardinal symptoms (abnormal gait, incontinence, cognitive impairment) + if necessary, positive lumbar tap test or 24-hour ICP recording.

  1. AD = Alzheimer’s disease; CT = computed tomography; EU = Europe; ICP = intracranial pressure; iNPH = normal pressure hydrocephalus; MRI = magnetic resonance imaging; PET = positron emission tomography; R = right; US = United States.
  2. aIn the 2 retrospective studies (n = 22), mean (SD) time between PET and biopsy was 620.91 (384.09) days.
  3. bIn Study A, a continuous variable regression model included percentage of area of Aβ plaque in biopsy sample tissue as measured by monoclonal antibody to Aβ, 4G8, as dependent variable; the [18F]flutemetamol PET standard uptake value ratio (SUVR) for the contralateral volume of interest (VOI) as independent variable; and interval from biopsy to PET scan as covariate. The result was significant for the model, and there was no apparent modulating influence of the interval from biopsy to PET scan (p > 0.21) [20]. The results of the analysis of ipsilateral SUVR VOIs were similar. The same results were achieved using time (in months) as a factor in a similar analysis in Study C (unpublished data).