PET/CT Imaging for Radiation Dosimetry, Plasma Pharmacokinetics, Biodistribution, Safety and Tolerability and Diagnostic Performance of BAY86-7548 in Patients With Prostate Cancer and Healthy Volunteers
This study has been completed.
Sponsor:
Piramal Imaging SA
Information provided by (Responsible Party):
Piramal Imaging SA
ClinicalTrials.gov Identifier:
NCT01205321
First received: September 17, 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 BAY86-7548 in patients with cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Diagnostic Imaging |
Drug: Bombesin (68Ga) labeled (BAY86-7548) |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Piramal Imaging SA:
Primary Outcome Measures:
- Visual assessment of lesions [ Time Frame: Day of study drug administration ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Quantitative analysis of BAY86-7548 uptake into lesions (Standardized Uptake Values = SUVs) [ Time Frame: Day of study drug administration ] [ Designated as safety issue: No ]
- ECG (significant abnormalities) [ Time Frame: At least 3 times until one day after treatment ] [ Designated as safety issue: Yes ]
- Blood pressure [ Time Frame: At least 3 times until one day after treatment ] [ Designated as safety issue: Yes ]
- Serum protein [ Time Frame: At least 3 times until one day after treatment ] [ Designated as safety issue: Yes ]
- Serum creatinine [ Time Frame: At least 3 times until one day after treatment ] [ Designated as safety issue: Yes ]
- Serum GOT (Glutamat-Oxalacetat-Transaminase) [ Time Frame: At least 3 times until one day after treatment ] [ Designated as safety issue: Yes ]
- Adverse events collection [ Time Frame: Continuously for at least 5 days after treatment ] [ Designated as safety issue: Yes ]
| Enrollment: | 19 |
| Study Start Date: | November 2010 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm 1 |
Drug: Bombesin (68Ga) labeled (BAY86-7548)
Cancer patients, single intravenous bolus injection of 140 MBq BAY86-7548 on day one of the treatment period, PET/CT
|
| Experimental: Arm 2 |
Drug: Bombesin (68Ga) labeled (BAY86-7548)
Healthy volunteers, single intravenous bolus injection of 140 MBq BAY86-7548 on day one of the treatment period, whole body PET/CT for determination of effective dose, kinetics of BAY86-7548 in blood
|
Eligibility| Ages Eligible for Study: | 45 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
-
Healthy volunteers:
- males, >/=50 and </= 65 years of age
-
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.
Contacts and Locations
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01205321
Please refer to this study by its ClinicalTrials.gov identifier: NCT01205321
Locations
| Finland | |
| Turku, Finland, FIN-20521 | |
| Germany | |
| Ulm, Baden-Württemberg, Germany, 89081 | |
| Switzerland | |
| Zürich, Switzerland, 8091 | |
Sponsors and Collaborators
Piramal Imaging SA
Investigators
| Study Director: | Bayer Study Director | Bayer |
More Information
Additional Information:
| Responsible Party: | Piramal Imaging SA |
| ClinicalTrials.gov Identifier: | NCT01205321 History of Changes |
| Other Study ID Numbers: | 14269 2008-008315-25 |
| Study First Received: | September 17, 2010 |
| Last Updated: | January 18, 2013 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices Finland: Finnish Medicines Agency Switzerland: Swissmedic |
Keywords provided by Piramal Imaging SA:
|
Neoplasm PET/CT diagnosis PET tracer |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases |
Bombesin Gastrin-Releasing Peptide Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Gastrointestinal Agents |
ClinicalTrials.gov processed this record on September 30, 2016