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Open-label, Multi Center PET/CT (Positron Emission Tomography/Computed Tomography) Study for Investigation of Safety, Tolerability, Biodistribution and Diagnostic Performance of the 68Ga Labeled PET Tracer BAY86-7548 Following a Single Intravenous Administration of 140 MBq (Corresponding to ≤ 28 µg Mass Dose) in Patients With Prostate Cancer as Well as Radiation Dosimetry, Plasma Pharmacokinetics, Biodistribution, Safety and Tolerability of the Tracer in PET/CT in Healthy Volunteers


Phase 1
45 Years
N/A
Not Enrolling
Male
Diagnostic Imaging

Thank you

Trial Information

Open-label, Multi Center PET/CT (Positron Emission Tomography/Computed Tomography) Study for Investigation of Safety, Tolerability, Biodistribution and Diagnostic Performance of the 68Ga Labeled PET Tracer BAY86-7548 Following a Single Intravenous Administration of 140 MBq (Corresponding to ≤ 28 µg Mass Dose) in Patients With Prostate Cancer as Well as Radiation Dosimetry, Plasma Pharmacokinetics, Biodistribution, Safety and Tolerability of the Tracer in PET/CT in Healthy Volunteers


Inclusion Criteria:



- Healthy volunteers:

- males, >/=50 and
- Cancer patients:

- males >/= 45 years of age

- Patients had an MRI of the prostate and/or a positive choline or acetate PET/CT
for diagnosis (Note: MRI, choline and acetate PET/CT are optional for primary
prostate cancer patients) of recurrence prostate cancer and the primary cancer
disease is/ will be histologically confirmed.

- The prostate cancer is histologically confirmed and results of histology are
available.

- Patients with primary prostate cancer: >/= 20 percent of biopsy material should
be affected by cancer in the histopathological evaluation.

- Patients with primary prostate cancer: Patient is scheduled to undergo
prostatectomy.

Exclusion Criteria:

- 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 BAY86-7548, unstable and uncontrolled
hypertension, chronic renal or hepatic disease, severe pulmonary disease) which could
compromise participation in the study

- Known sensitivity to the study drug or components of the preparation.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Visual assessment of lesions

Outcome Time Frame:

Day of study drug administration

Safety Issue:

No

Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:

Bayer

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

14269

NCT ID:

NCT01205321

Start Date:

November 2010

Completion Date:

December 2011

Related Keywords:

  • Diagnostic Imaging
  • Neoplasm
  • PET/CT diagnosis
  • PET tracer
  • Prostatic Neoplasms

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