Exploration of Tumor Accumulation of BAY94-9392 in Patients With Cancer
NCT ID: NCT01186601
Last Updated: 2014-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
30 participants
INTERVENTIONAL
2010-12-31
2011-10-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Arm 1
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* Known sensitivity to the study drug or components of the preparation
* Previous treatment with BAY94-9392 in this study
18 Years
90 Years
ALL
No
Sponsors
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Life Molecular Imaging SA
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Stanford, California, United States
Countries
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References
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Park SY, Na SJ, Kumar M, Mosci C, Wardak M, Koglin N, Bullich S, Mueller A, Berndt M, Stephens AW, Cho YM, Ahn H, Chae SY, Kim HO, Moon DH, Gambhir SS, Mittra ES. Clinical Evaluation of (4S)-4-(3-[18F]Fluoropropyl)-L-glutamate (18F-FSPG) for PET/CT Imaging in Patients with Newly Diagnosed and Recurrent Prostate Cancer. Clin Cancer Res. 2020 Oct 15;26(20):5380-5387. doi: 10.1158/1078-0432.CCR-20-0644. Epub 2020 Jul 21.
Mittra ES, Koglin N, Mosci C, Kumar M, Hoehne A, Keu KV, Iagaru AH, Mueller A, Berndt M, Bullich S, Friebe M, Schmitt-Willich H, Gekeler V, Fels LM, Bacher-Stier C, Moon DH, Chin FT, Stephens AW, Dinkelborg LM, Gambhir SS. Pilot Preclinical and Clinical Evaluation of (4S)-4-(3-[18F]Fluoropropyl)-L-Glutamate (18F-FSPG) for PET/CT Imaging of Intracranial Malignancies. PLoS One. 2016 Feb 18;11(2):e0148628. doi: 10.1371/journal.pone.0148628. eCollection 2016.
Other Identifiers
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15329
Identifier Type: -
Identifier Source: org_study_id