Trial record 1 of 3 for:
david kirsch
Cathepsin Activatable Fluorescent Probe (LUM015)
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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. |
ClinicalTrials.gov Identifier: NCT01626066 |
Recruitment Status :
Completed
First Posted : June 22, 2012
Last Update Posted : December 9, 2015
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Sponsor:
David Kirsch
Collaborator:
American Society of Clinical Oncology
Information provided by (Responsible Party):
David Kirsch, Duke University
Tracking Information | ||||
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First Submitted Date ICMJE | June 20, 2012 | |||
First Posted Date ICMJE | June 22, 2012 | |||
Last Update Posted Date | December 9, 2015 | |||
Study Start Date ICMJE | June 2012 | |||
Actual Primary Completion Date | August 2014 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Dose of LUM015 in mg [ Time Frame: 24 hours ] Dose of LUM015 in mg that is tolerated and labels tumors
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
Mean number of fluorescence counts per second per square centimeter [ Time Frame: At time of surgery ] | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Cathepsin Activatable Fluorescent Probe | |||
Official Title ICMJE | A Phase I Study of the Safety and Activation of a Cathepsin-Activatable Fluorescent Cancer Specific Probe LUM015 | |||
Brief Summary | Real-time detection of cancer cells during surgical removal of a tumor is important. Currently when tissue is removed at the time of surgery, the removed tissue goes to pathology when the margins (edges of the tissue) are examined to see if cancer cells are present. This may take a few to several days. Patients tissue with positive (cancer cells present) margins may require additional therapies including surgery. The purpose of this study is to determine a safe dose of a new imaging agent (LUM015), like a fluorescent contrast agent or dye, that will show in the tumor area during surgery and may help facilitate visualization of tumor for its removal. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Diagnostic |
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Condition ICMJE |
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Intervention ICMJE | Drug: LUM015
LUM015 assigned dose given once by IV push
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Study Arms ICMJE | Experimental: LUM015
Receive single dose of LUM015 through a vein in the arm the day prior to surgery
Intervention: Drug: LUM015
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
15 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | August 2015 | |||
Actual Primary Completion Date | August 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 74 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01626066 | |||
Other Study ID Numbers ICMJE | Pro00035444 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | David Kirsch, Duke University | |||
Original Responsible Party | Duke University | |||
Current Study Sponsor ICMJE | David Kirsch | |||
Original Study Sponsor ICMJE | Duke University | |||
Collaborators ICMJE | American Society of Clinical Oncology | |||
Investigators ICMJE |
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PRS Account | Duke University | |||
Verification Date | December 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |