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
1 other identifier
interventional
6
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Mar 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 31, 2017
CompletedFirst Submitted
Initial submission to the registry
April 3, 2017
CompletedFirst Posted
Study publicly available on registry
April 12, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 12, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 12, 2018
CompletedApril 17, 2018
April 1, 2018
1 year
April 3, 2017
April 16, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Zr-DFO-pertuzumab (89Zr-DFO-pertuzumab) PET/CT
EXPERIMENTALZr-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.
Interventions
Zr-DFO-pertuzumab studies will be performed as hybrid PET/CT examinations with known HER2-positive malignancy
Eligibility Criteria
You may qualify if:
- Age 21 years or greater
- Any biopsy proven HER2-positive malignancy. ASCO guidelines will be used to define HER2-positivity for breast cancer. Similar guidelines will be used for other cancer types as appropriate.
- At least one malignant lesion on CT, MR, or FDG PET/CT within 60 days of protocol enrollment
- ECOG performance of 0-2
You may not qualify if:
- Life expectancy \< 3 months
- Pregnancy or lactation
- Patients who cannot undergo PET/CT scanning because of weight limits. PET/CT scanners may not be able to function with patients over 450 pounds.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Memorial Slaon-Kettering Cancer Center
New York, New York, 10065, United States
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Gary Ulaner, MD, PhD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 3, 2017
First Posted
April 12, 2017
Study Start
March 31, 2017
Primary Completion
April 12, 2018
Study Completion
April 12, 2018
Last Updated
April 17, 2018
Record last verified: 2018-04