check_circleStudy Completed
Neoplasms
Bayer Identifier:
15329
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Exploration of tumor accumulation of BAY94-9392 in patients with cancer
Trial purpose
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.
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.
Key Participants Requirements
Sex
BothAge
18 - 90 YearsTrial summary
Enrollment Goal
30Trial Dates
December 2010 - October 2011Phase
Phase 1Could I Receive a placebo
NoProducts
PET tracer (BAY94-9392)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Stanford Hospital & Clinics | Stanford, 94305, United States |
Primary Outcome
- Evaluation of the accumulation of BAY94-9392 in primary cancer lesions confirmed by histology.date_rangeTime Frame:Day 1enhanced_encryptionYesSafety Issue:
- 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.date_rangeTime Frame:Day 1enhanced_encryptionYesSafety Issue:
Secondary Outcome
- Standardized uptake value (SUV)date_rangeTime Frame:Day 1enhanced_encryptionNoSafety Issue:
- Standardized uptake value ratio (SUVR)date_rangeTime Frame:Day 1enhanced_encryptionNoSafety Issue:
- Vital Signsdate_rangeTime Frame:Day 1 and Day 2enhanced_encryptionYesSafety Issue:
- Laboratory Findingsdate_rangeTime Frame:Day 1 and Day 2enhanced_encryptionYesSafety Issue:
- Electrocardiograms (ECGs)date_rangeTime Frame:Day 1 and Day 2enhanced_encryptionYesSafety Issue:
- Adverse Event Collectiondate_rangeTime Frame:Day 1 and Day 2enhanced_encryptionYesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
DiagnosticAllocation
N/ABlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1