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Luke Nordquist, MD, FACP, CEO
drluke@xcancer.comTony Romero, MS, CCRC, Director of Research
tromero@gucancer.comPET/CT Imaging for Radiation Dosimetry, Plasma Pharmacokinetics, Safety and Tolerability in Healthy Volunteers and Safety, Tolerability and Diagnostic Performance of BAY86-9596 in Patients With Non-small Cell Lung Cancer, Breast Cancer, Head and Neck Cancer and Patients With Inflammations
Description:
Visual assessment of diagnostic PET/CT (positron emission tomography/computed tomography) images obtained after a single intravenous injection of BAY86-9596 in patients with cancer and inflammation
Sponsor:
Unknown Organization
Phase:
Phase 1
Contacts:
Bayer Study Director (STUDY_DIRECTOR)Government Study Link:
NCT01089998 - Click here to see study onClinicalTrials.gov
BAY86-9596
Isotope(s):
FLUORINE-18
Radioisotope: F-18
Theranostic Role: PET Imaging
T1/2 (Half-Life): 1.8 Hours
Decay Mode: POSITRON β+ (96.7%), ELECTRON CAPTURE (3.3%), GAMMA 511 keV
Energy: Eβ+ 635 keV
Range: N/A
Decay Daughters: O18 (Stable)
Status: FDA Approvals: FDG (Cancer 2005): GLUDEF®, METATRACE® AXUMIN® (2016), PYLARIFY® (2023), POSLUMA® (2024)
Target(s):
- PD-L1
Ligand Class: Small Molecules
BAY86-9596
Isotope(s):
FLUORINE-18
Radioisotope: F-18
Theranostic Role: PET Imaging
T1/2 (Half-Life): 1.8 Hours
Decay Mode: POSITRON β+ (96.7%), ELECTRON CAPTURE (3.3%), GAMMA 511 keV
Energy: Eβ+ 635 keV
Range: N/A
Decay Daughters: O18 (Stable)
Status: FDA Approvals: FDG (Cancer 2005): GLUDEF®, METATRACE® AXUMIN® (2016), PYLARIFY® (2023), POSLUMA® (2024)
Target(s):
- PD-L1
Ligand Class: Small Molecules
BAY86-9596
Isotope(s):
FLUORINE-18
Radioisotope: F-18
Theranostic Role: PET Imaging
T1/2 (Half-Life): 1.8 Hours
Decay Mode: POSITRON β+ (96.7%), ELECTRON CAPTURE (3.3%), GAMMA 511 keV
Energy: Eβ+ 635 keV
Range: N/A
Decay Daughters: O18 (Stable)
Status: FDA Approvals: FDG (Cancer 2005): GLUDEF®, METATRACE® AXUMIN® (2016), PYLARIFY® (2023), POSLUMA® (2024)
Target(s):
- PD-L1
Ligand Class: Small Molecules
FDG
Isotope(s):
FLUORINE-18
Radioisotope: F-18
Theranostic Role: PET Imaging
T1/2 (Half-Life): 1.8 Hours
Decay Mode: POSITRON β+ (96.7%), ELECTRON CAPTURE (3.3%), GAMMA 511 keV
Energy: Eβ+ 635 keV
Range: N/A
Decay Daughters: O18 (Stable)
Status: FDA Approvals: FDG (Cancer 2005): GLUDEF®, METATRACE® AXUMIN® (2016), PYLARIFY® (2023), POSLUMA® (2024)
Target(s):
- Glucose Transport
Ligand Class: Small Molecules
Inclusion
- Cancer patients and inflammation patients (inflammation patients in study part 2 = optional, in study part 3 mandatory)
- Males/females ≥ 50 years and ≤ 65 years of age
- patients had an FDG PET/CT for detection, or staging, or restaging, or therapy response assessment that still showed tumor mass with high certainty, for
- * Healthy volunteers only
- Males/females ≥ 30 and ≤ 80 years of age
Exclusion
- * Exclusion criteria for all healthy volunteers and patients:
- any concomitant disease (for healthy volunteers) and for patients any concurrent severe and/or uncontrolled and/or unstable other medical disease (e.g. poorly controlled diabetes, congestive heart failure, myocardial infarction within 12 months prior to planned injection of BAY86-9596, unstable and uncontrolled hypertension, chronic renal or hepatic disease, severe pulmonary disease) which could compromise participation in the study
- For healthy volunteers and patients: known sensitivity to the study drug or components of the preparation.
- tumor patients with known inflammatory disease, where images overlap inflammatory lesions with tumor lesions
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