Radiation Dosimetry, Metabolism, Pharmacokinetics, Safety and Tolerability and PET Imaging With BAY94-9392 in Healthy Volunteers and Patients With Cancer or Inflammation
This study has been completed.
Sponsor:
Piramal Imaging SA
Information provided by (Responsible Party):
Piramal Imaging SA
ClinicalTrials.gov Identifier:
NCT01103310
First received: March 31, 2010
Last updated: January 18, 2013
Last verified: January 2013
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Purpose
Visual assessment of diagnostic PET/CT (positron emission tomography/computed tomography) images obtained after a single intravenous injection of BAY94-9392 in patients with cancer or inflammation.
| Condition | Intervention | Phase |
|---|---|---|
|
Diagnostic Imaging Neoplasms |
Drug: BAY94-9392 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Open-label, Multi Center Study for an Evaluation of Radiation Dosimetry, Plasma Pharmacokinetics, Safety and Tolerability of the 18F-labeled PET/CT (Positron Emission Tomography / Computed Tomography) Tracer BAY94-9392 Following a Single Intravenous Administration of 300 MBq (Corresponding to ≤ 100 µg Total Quantity) in Healthy Volunteers, as Well as the Investigation of Safety, Tolerability, Pharmacokinetics, and Diagnostic Performance of the Tracer in PET/CT in Cancer Patients or Patients With Inflammation. |
Resource links provided by NLM:
Further study details as provided by Piramal Imaging SA:
Primary Outcome Measures:
- Visual assessment of lesion [ Time Frame: Day of study drug administration ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Quantitative analysis of BAY94-9392 uptake into lesions (Standardized Uptake Values = SUVs) [ Time Frame: Day of study drug administration ] [ Designated as safety issue: No ]
- Electrocardiogram (ECG) [ Time Frame: At least twice within 2 days after treatment ] [ Designated as safety issue: Yes ]
- Blood pressure [ Time Frame: At least twice within 2 days after treatment ] [ Designated as safety issue: Yes ]
- Serum protein [ Time Frame: At least twice within 2 days after treatment ] [ Designated as safety issue: Yes ]
- Serum creatinine [ Time Frame: At least twice within 2 days after treatment ] [ Designated as safety issue: Yes ]
- Serum GOT (Glutamate-Oxalacetate-Transaminase) [ Time Frame: At least twice within 2 days after treatment ] [ Designated as safety issue: Yes ]
- Adverse events collection [ Time Frame: Continuously for at least 4 days after treatment ] [ Designated as safety issue: Yes ]
| Enrollment: | 46 |
| Study Start Date: | April 2010 |
| Study Completion Date: | August 2011 |
| Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm 1
Cancer patients, single intravenous bolus injection of 300 MBq BAY94-9392 on day one of the treatment period, PET/CT
|
Drug: BAY94-9392 |
|
Experimental: Arm 2
Healthy volunteers, single intravenous bolus injection of 300 MBq BAY94-9392 on day one of the treatment period, whole body PET/CT for determination of effective dose, kinetics of BAY94-9392 in blood
|
Drug: BAY94-9392 |
Eligibility| Ages Eligible for Study: | 35 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion criteria:
In Germany Healthy volunteers
- Males/females ≥ 50 and ≤ 65 years Patients
- Males/females ≥ 35 and ≤ 75 years
- histologically confirmed diagnosis of non small cell lung cancer or adenocarcinoma of the breast with a positive FDG-PET or
- patient with primary prostate cancer scheduled for prostatectomy and patient with prostate tumor recurrence with a positive choline-PET, the initial disease is histologically confirmed or
- inflammation with a positive FDG-PET
In Korea Patients
- Males/females ≥ 35 and ≤ 75 years
- histologically confirmed diagnosis of non small cell lung cancer, adenocarcinoma of the breast or hepatocellular cancer with a positive FDG-PET or
- patient with primary prostate cancer scheduled for prostatectomy and patient with prostate tumor recurrence with a positive choline-PET, the initial disease is histologically confirmed or
- inflammation (positive FDG-PET mandatory, could be also done as screening examination)
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 BAY 94-9392, 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01103310
Locations
| United States, California | |
| Stanford, California, United States, 94305 | |
| Germany | |
| München, Bayern, Germany, 81675 | |
| Korea, Republic of | |
| Seoul, Korea, Republic of, 138-736 | |
Sponsors and Collaborators
Piramal Imaging SA
Investigators
| Study Director: | Bayer Study Director | Bayer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Piramal Imaging SA |
| ClinicalTrials.gov Identifier: | NCT01103310 History of Changes |
| Other Study ID Numbers: | 14207, 2008-008316-15 |
| Study First Received: | March 31, 2010 |
| Last Updated: | January 18, 2013 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices Korea: Food and Drug Administration |
Keywords provided by Piramal Imaging SA:
|
Neoplasm PET/CT diagnosis PET tracer |
Additional relevant MeSH terms:
|
Neoplasms Inflammation Pathologic Processes |
ClinicalTrials.gov processed this record on May 23, 2013