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Open-label Study for an Exploration of Tumor Accumulation of the 18F Labeled PET/CT (Positron Emission Tomography / Computed Tomography) Tracer BAY94-9392 Following a Single Intravenous Administration of 300 MBq (Corresponding to


Phase 1
18 Years
90 Years
Not Enrolling
Both
Neoplasms

Thank you

Trial Information

Open-label Study for an Exploration of Tumor Accumulation of the 18F Labeled PET/CT (Positron Emission Tomography / Computed Tomography) Tracer BAY94-9392 Following a Single Intravenous Administration of 300 MBq (Corresponding to


Inclusion Criteria:



- Males/females >/= 18 years

- Patients with a diagnosis of primary prostate cancer (biopsy proven) and scheduled
for radical prostatectomy or patients with prostate tumor recurrence (Patients with
advanced tumor disease and a high likelihood to display lymph node metastasis are to
be preferably included.)

- ECOG (Eastern Cooperative Oncology Group) performance status of 0-2, determined
within one week prior to treatment with BAY94-9392

- Patient had an [18F]-fluorodeoxyglucose (FDG) PET/CT for detection, or staging, or
restaging, or therapy response assessment that still showed tumor mass with high
certainty for a cancer such as melanoma, or colorectal cancer, or head & neck cancer
for which FDG-PET/CT is used in clinical routine, and the primary cancer disease is
histologically confirmed. In case of recurrent disease confirmation of the primary
tumor is sufficient

- No clinically relevant deviations in renal function as determined by Cockcroft and
Gault method using serum creatinine at screening.

Exclusion Criteria:

- Concurrent severe and/or uncontrolled and/or unstable medical disease other than
cancer or inflammation (e.g. poorly controlled diabetes, congestive heart failure,
myocardial infarction within 12 months prior to planned injection of BAY94-9392,
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

- Previous treatment with BAY94-9392 in this study

Type of Study:

Interventional

Study Design:

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Evaluation of the accumulation of BAY94-9392 in primary cancer lesions confirmed by histology.

Outcome Time Frame:

Day 1

Safety Issue:

Yes

Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:

Bayer

Authority:

United States: Food and Drug Administration

Study ID:

15329

NCT ID:

NCT01186601

Start Date:

December 2010

Completion Date:

October 2011

Related Keywords:

  • Neoplasms
  • Prostatic Neoplasms
  • Colorectal Neoplasms
  • Head and Neck Neoplasms
  • Melanoma
  • Neoplasm Metastasis
  • Neoplasms

Name

Location

Fountain Valley, California  92708