Exploration of Tumor Accumulation of BAY94-9392 in Patients With Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01186601
Recruitment Status : Completed
First Posted : August 23, 2010
Last Update Posted : November 13, 2014
Information provided by (Responsible Party):
Piramal Imaging SA

Brief Summary:

The study will be conducted as an open label, single-dose, explorative study with patients with histologically proven cancer and, preferably, tumor positive lesions in previously performed nuclear medicine imaging examinations.

The investigational drug will be given as a single administration in a dose of </= 0.1 mg BAY94-9392 (300 MBq, +/- 10%). The total duration of the study for each patient will be approximately 8 days.

Condition or disease Intervention/treatment Phase
Neoplasms Drug: PET tracer (BAY94-9392) Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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 </= 0.1 mg Total Quantity) in Patients With Prostate Cancer or Other Malignant Tumors
Study Start Date : December 2010
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Arm 1 Drug: PET tracer (BAY94-9392)
A radioactive dose of 300 MBq of the study drug with a total quantity of </= 0.1 mg will be administered as slow intravenous bolus injection over up to 60 seconds

Primary Outcome Measures :
  1. Evaluation of the accumulation of BAY94-9392 in primary cancer lesions confirmed by histology. [ Time Frame: Day 1 ]
  2. Evaluation of the accumulation of BAY94-9392 in known or suspected local and/or systemic recurrent cancer lesions and/or lymph node metastasis or distant metastasis. [ Time Frame: Day 1 ]

Secondary Outcome Measures :
  1. Standardized uptake value (SUV) [ Time Frame: Day 1 ]
  2. Standardized uptake value ratio (SUVR) [ Time Frame: Day 1 ]
  3. Vital Signs [ Time Frame: Day 1 and Day 2 ]
  4. Laboratory Findings [ Time Frame: Day 1 and Day 2 ]
  5. Electrocardiograms (ECGs) [ Time Frame: Day 1 and Day 2 ]
  6. Adverse Event Collection [ Time Frame: Day 1 and Day 2 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01186601

United States, California
Stanford, California, United States, 94305
Sponsors and Collaborators
Piramal Imaging SA
Study Director: Bayer Study Director Bayer