PET Imaging With Cu-64 Labeled Trastuzumab in HER2+ Metastatic Breast Cancer (Cu-64 HER2+)
This study is ongoing, but not recruiting participants.
Sponsor:
Memorial Sloan-Kettering Cancer Center
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00605397
First received: January 18, 2008
Last updated: October 29, 2012
Last verified: October 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Breast Cancer |
Radiation: PET Imaging With Cu-64 Labeled Trastuzumab |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Pilot Trial of PET Imaging With Cu-64 Labeled Trastuzumab in HER2+ Metastatic Breast Cancer |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
Drug Information available for:
Trastuzumab
U.S. FDA Resources
Further study details as provided by Memorial Sloan-Kettering Cancer Center:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
- to determine the pharmacokinetic profile of the 64Cu-trastuzumab radiotracer. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]
| Enrollment: | 11 |
| Study Start Date: | January 2007 |
| Estimated Study Completion Date: | January 2013 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
breast cancer pt receiving trastuzumab therapy will undergo two complete PET studies.
|
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.
|
|
Experimental: 2
breast cancer pt receiving trastuzumab therapy will undergo one complete PET studies
|
Radiation: PET Imaging With Cu-64 Labeled Trastuzumab
The remaining 20 patients will undergo one PET study.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00605397
Locations
| United States, New York | |
| Memorial Sloan Kettering Cancer Center | |
| New York, New York, United States, 10065 | |
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
| Principal Investigator: | Jorge Carrasquillo, MD | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00605397 History of Changes |
| Other Study ID Numbers: | 06-134 |
| Study First Received: | January 18, 2008 |
| Last Updated: | October 29, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Memorial Sloan-Kettering Cancer Center:
|
Cu-64 LABELED TRASTUZUMAB |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
Trastuzumab Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013