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Sponsored by: |
Memorial Sloan-Kettering Cancer Center |
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Information provided by: | Memorial Sloan-Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT00613847 |
The purpose of this study is to learn more about how a new study agent works inside the body. This study agent is a protein called 68Ga-F(ab')2-trastuzumab fragments (HERScan). This is a radioactive tracer that was developed at MSKCC to target the HER2 protein on cancer cells. By giving this tracer to patients whose cancers have the HER2 protein, we hope to be able to see the level of HER2 on the cancer cells using PET scanning.
Condition | Intervention |
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Solid Tumors |
Procedure: PET Scan |
Study Type: | Interventional |
Study Design: | Diagnostic, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Biodistribution and Dosimetry of Serial PET Imaging With Ga-68 Labeled F(ab') 2- Trastuzumab |
Estimated Enrollment: | 30 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | October 2010 |
Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Patients with invasive solid tumors
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Procedure: PET Scan
Pt will undergo one PET study following the i.v. administration of 10mCi of 68Ga-F(ab')2-trastuzumab fragments (HERScan). The PET study will be performed within 4 weeks of the patient's most recent imaging studies. A subset of 10 patients who have evidence of tumor uptake and localization with the 68Ga-F(ab')2-trastuzumab fragments will be asked to undergo follow-up PET scans (up to a maximum of 3) to examine the time course of HER-2 expression. These follow-up PET scans will be performed concurrently with the patient's standard imaging studies to evaluate response to their current therapy as per their treating physicians.
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2: Active Comparator
Patients with advanced solid tumors that express HER2 with tumors that are HER2 1+ by IHC or FISH.
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Procedure: PET Scan
Once safety and feasibility has been established in this group, then enrollment to the HER2 1+ cohort will commence. Pt will undergo one PET study following the i.v. administration of 10mCi of 68Ga-F(ab')2-trastuzumab fragments (HERScan). The PET study will be performed within 4 weeks of the patient's most recent imaging studies. A subset of 10 patients who have evidence of tumor uptake and localization with the 68Ga-F(ab')2-trastuzumab fragments will be asked to undergo follow-up PET scans (up to a maximum of 3) to examine the time course of HER-2 expression. These follow-up PET scans will be performed concurrently with the patient's standard imaging studies to evaluate response to their current therapy as per their treating physicians.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Tim Akhurst, MD | akhurstt@mskcc.org | |
Contact: David Solit, MD | solitd@mskcc.org |
United States, New York | |
Memorial Sloan Kettering Cancer Center | Recruiting |
New York, New York, United States, 10065 | |
Contact: Tim Akhurst, MD akhurstt@mskcc.org | |
Contact: David Solit, MD solitd@mskcc.org | |
Principal Investigator: David Akhurst, MD |
Principal Investigator: | Tim Akhurst, MD | Memorial Sloan-Kettering Cancer Center |
Responsible Party: | Memorial Sloan-Kettering Cancer Center ( Tim Akhurst, MD ) |
Study ID Numbers: | 06-090 |
Study First Received: | January 21, 2008 |
Last Updated: | March 4, 2009 |
ClinicalTrials.gov Identifier: | NCT00613847 History of Changes |
Health Authority: | United States: Food and Drug Administration |
PET Scan Invasive Solid Tumors |
Trastuzumab |
Antineoplastic Agents Therapeutic Uses Trastuzumab Pharmacologic Actions |