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Trial record 12 of 189 for:    pertuzumab

Imaging With a New Agent That Finds a Cancer Protein Called HER2

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. Identifier: NCT03109977
Recruitment Status : Completed
First Posted : April 12, 2017
Last Update Posted : April 18, 2018
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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.

Condition or disease Intervention/treatment Phase
HER2-positive Carcinoma HER2-positive Primary Malignancy Drug: Zr-DFO-pertuzumab PET/CT Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: First-in-human Imaging With 89Zr-DFO-pertuzumab in Patients With HER2 Positive Malignancies
Actual Study Start Date : March 31, 2017
Actual Primary Completion Date : April 12, 2018
Actual Study Completion Date : April 12, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Pertuzumab

Arm Intervention/treatment
Experimental: Zr-DFO-pertuzumab (89Zr-DFO-pertuzumab) PET/CT
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.
Drug: Zr-DFO-pertuzumab PET/CT
Zr-DFO-pertuzumab studies will be performed as hybrid PET/CT examinations with known HER2-positive malignancy

Primary Outcome Measures :
  1. Number of Participants With Treatment-Related Adverse Events, including vital signs as Assessed by CTCAE v4.0 [ Time Frame: 1 year ]
    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03109977

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United States, New York
Memorial Slaon-Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
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Principal Investigator: Gary Ulaner, MD, PhD Memorial Sloan Kettering Cancer Center

Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center Identifier: NCT03109977    
Other Study ID Numbers: 17-059
First Posted: April 12, 2017    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
Additional relevant MeSH terms:
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Antineoplastic Agents, Immunological
Antineoplastic Agents