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Trial record 4 of 18 for:    cu-64

PET Imaging With Cu-64 Labeled Trastuzumab in HER2+ Metastatic Breast Cancer (Cu-64 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.
ClinicalTrials.gov Identifier: NCT00605397
Recruitment Status : Completed
First Posted : January 31, 2008
Last Update Posted : December 28, 2015
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Tracking Information
First Submitted Date  ICMJE January 18, 2008
First Posted Date  ICMJE January 31, 2008
Last Update Posted Date December 28, 2015
Study Start Date  ICMJE January 2007
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 30, 2008)
test safety & feas of (PET) imaging w radiolabeled 64Cu-trastuzumab to determine dosimetry & biodistribution of trastuzumab, using a radiotracer dilution technique w copper-64 labeled trastuzumab [ Time Frame: conclusion of study ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00605397 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2008)
  • to determine reproducibility of the measurement of the Standardized Uptake Value (SUV) in normal organs and tumors in a sub-cohort of 8 patients who will undergo two injections of the tracer. [ Time Frame: conclusion of study ]
  • to determine the pharmacokinetic profile of the 64Cu-trastuzumab radiotracer. [ Time Frame: conclusion of study ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PET Imaging With Cu-64 Labeled Trastuzumab in HER2+ Metastatic Breast Cancer
Official Title  ICMJE Pilot Trial of PET Imaging With Cu-64 Labeled Trastuzumab in HER2+ Metastatic Breast Cancer
Brief Summary The purpose of this study is to learn more about how a new study agent works inside the body. The study agent is a protein called 64Cu-trastuzumab. This is a radioactive tracer that was developed at MSKCC to target HER2 protein on cancer cells. A radioactive tracer is a small amount of radioactive dye that follows something else that is not radioactive In this study the study agent, 64Cu-trastuzumab, is the tracer and what's being followed is trastuzumab (Herceptin™). By giving you this tracer after you have treatment with trastuzumab (Herceptin™), we will be able to use PET scans to show us which parts of your body and tumor sites the Herceptin goes to. This will help us to understand better how Herceptin works in the body to fight cancer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Radiation: PET Imaging With Cu-64 Labeled Trastuzumab
    The first 8 patients enrolled will undergo two complete PET studies, up to 3-6 weeks apart, to assess for reproducibility of measures of tracer uptake into individual organs and known sites of metastatic disease.
  • Radiation: PET Imaging With Cu-64 Labeled Trastuzumab
    The remaining 20 patients will undergo one PET study.
Study Arms  ICMJE
  • Experimental: 1
    breast cancer pt receiving trastuzumab therapy will undergo two complete PET studies.
    Intervention: Radiation: PET Imaging With Cu-64 Labeled Trastuzumab
  • Experimental: 2
    breast cancer pt receiving trastuzumab therapy will undergo one complete PET studies
    Intervention: Radiation: PET Imaging With Cu-64 Labeled Trastuzumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 10, 2010)
11
Original Estimated Enrollment  ICMJE
 (submitted: January 30, 2008)
28
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Registered patient at MSKCC
  • Age ≥18 years
  • Patients with HER2+ metastatic breast cancer (either 3+ by immunohistochemistry or with evidence of gene amplification (>2.0) by fluorescence in situ hybridization (FISH))
  • Measurable or evaluable disease
  • Currently taking or about to commence treatment with trastuzumab at a dosing schedule of 2 mg/kg weekly or 6 mg/kg every three weeks, as per standard of care
  • Karnofsky Performance Score ≥ 60
  • Signed informed consent

Exclusion Criteria:

  • Previous Grade 3 or higher allergic reaction to trastuzumab that resulted in discontinuation of trastuzumab therapy
  • Claustrophobia/pain leading to inability to lie still for the duration of the scanning procedure.
  • Pregnancy Test to be performed on female patients of childbearing potential within 24hrs before administration of radioactive material.
  • Inability to provide written informed consent.
  • Patients with liver metastases as the only site of distant disease
  • Patients with known sensitivity or contraindication to Herceptin.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (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 NCT00605397
Other Study ID Numbers  ICMJE 06-134
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor  ICMJE Memorial Sloan Kettering Cancer Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jorge Carrasquillo, MD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP