PET/CT Imaging with administration of [F-18] RGD-K5

Carotid Arteries

PET Imaging/scan with [F-18] RGD-K5, PET Imaging/scan with RGD-K5, PET Imaging/scan with K5

PET/CT Imaging with [F-18] RGD-K5

Cedars-Sinai Medical Center

TRACER [F-18] RDG-K5 Carotid Plaque Imaging Study

An Exploratory, Phase II, Open Label, Single-Center, Non-Randomized Study Of [F-18] RGD-K5 Positron Emission Tomography (PET) In Participants With Carotid Artery Stenosis

To assess the uptake of [F-18] RGD-K5 by carotid plaque with PET/MRI imaging in participants prior to carotid endarterectomy and thereby determine if carotid plaque that causes significant stenosis [in participants being considered for carotid endarterectomy (CEA)] is characterized by increased integrin expression and enhanced angiogenesis.

to collect safety data of [F-18] RGD-K5 when given with PET/MRI imaging

Balaji Tamarappoo

Staff, Cardiac Imaging

Bolus injection of 0.025 mmol/kg body weight (0.1 ml/kg BW) of Gadoxetic Acid Disodium (Primovist, BAY86-4873). Single i.v. injection during MRI procedure, with one contrast-enhanced MRI procedure per patient

Gadoxetic Acid Disodium (Primovist, BAY86-4873)

Sex: Female, Male

Characterization of first liver lesion type of referral diagnosis

Characterization of second liver lesion type of referral diagnosis

Characterization of third liver lesion type of referral diagnosis

Three Blinded Readers performed lesion detection in pre- and post-contrast MRI image sets. Per Blinded Reader/image set combination, sensitivity of lesion detection was calculated, as: (number of lesions detected in the reader/image set combination)/(number of lesions in Standard of Reference)*100%. Then, difference in sensitivity of lesion detection for post- minus pre-contrast MRI images (in percentage points) was calculated for each Blinded Reader.

Difference in Sensitivity of Lesion Detection in MRI Images (Post-contrast MRI Minus Pre-contrast MRI) Measured as Percentage Points

The on-site investigators performed lesion detection in pre- and post-contrast MRI image sets. Per image set, sensitivity of lesion detection was calculated, as: (number of lesions detected in image set)/(number of lesions in Standard of Reference)*100%. Then, difference in sensitivity of lesion detection for post- minus pre-contrast MRI (in percentage points) was calculated.

Difference in Sensitivity of Lesion Detection in MRI Images (Post-contrast MRI Minus Pre-contrast MRI) Assessed by Investigators Measured in Percentage Points

Three Blinded Reader performed lesion characterization in pre- and combined pre-/post-contrast MRI image set. Per Blinded Reader/image set combination, precision of lesion characterization was calculated: (number of unique Standard of Reference-matched characterizations detected for the Reader/image set combination)/(number of unique lesion characterizations in Standard of Reference)*100%. Then, difference in precision of lesion characterization for post- minus combined pre-/post-contrast MRI (in percentage points) was calculated for each Blinded Reader.

Difference in Precision of Lesion Characterization (Combined Pre- and Post-contrast Minus Pre-contrast MRI) Measured in Percentage Points

Overall Study

Therapeutic Area Head

Known or Suspected Focal Liver Lesions

Efficacy and Safety of Primovist in Chinese Patients

A Multicenter, Open-label Phase III Study of the Efficacy and Safety of Primovist as a Contrast Agent for Enhanced MR Imaging of Focal Liver Lesions in Chinese Patients

nephrogenic fibrosing dermopathy/nausea

TRACER [F-18] RDG-K5 Carotid Plaque Imaging Study

Efficacy and Safety of Primovist in Chinese Patients

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