NCT03109977|CompletedPhase 1FDA Drug
Imaging With a New Agent That Finds a Cancer Protein Called HER2
First-in-human Imaging With 89Zr-DFO-pertuzumab in Patients With HER2 Positive Malignancies
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Sponsor study identifier
interventional
6
1 country
1
Study Start
March 31, 2017
Actual (reported)Primary Completion
April 12, 2018
Actual (reported)Study Completion
April 12, 2018
Actual (reported)The purpose of this study is to test if an imaging agent called Zr-DFO-pertuzumab that finds HER2 proteins can be used to take pictures of HER2-positive cancer.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 12, 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 31, 2017
Actual (reported)April 3, 2017
Actual (reported)April 12, 2017
Actual (reported)April 12, 2018
Actual (reported)April 12, 2018
Actual (reported)Number of Participants With Treatment-Related Adverse Events, including vital signs as Assessed by CTCAE v4.0
Patients will be monitored closely for evidence of adverse events, including vital signs before and after tracer administration. The day after tracer administration, a physician will screen for any side effects requiring treatment. If a severe adverse effect (Common Terminology Criteria for Adverse Events grade 3 or 4) attributable to 89Zr-DFO-pertuzumab occurs in any patient, then further use of 89Zr-DFO-pertuzumab will be suspended and the protocol reviewed with the MSKCC Data Safety Monitoring Committee.
1 year
Zr-DFO-pertuzumab (89Zr-DFO-pertuzumab) PET/CT will be performed in patients with known HER2-positive malignancy. Patients with multifocal disease, as demonstrated on cross-sectional imaging studies, will be preferentially recruited.
Zr-DFO-pertuzumab studies will be performed as hybrid PET/CT examinations with known HER2-positive malignancy
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Memorial Slaon-Kettering Cancer Center
New York, New York, 10065, United States
Gary Ulaner, MD, PhD
Memorial Sloan Kettering Cancer Center
6 participants (actual enrollment reported by the registry).
First Submitted
April 3, 2017
First Posted
April 12, 2017
Study Start
March 31, 2017
Actual (reported)Primary Completion
Contact the study team to confirm eligibility.
April 12, 2018
Actual (reported)Study Completion
April 12, 2018
Actual (reported)Last Updated
April 17, 2018
Record last verified: 2018-04
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Source: ClinicalTrials.gov.
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