Biodistribution and Dosimetry of Serial PET Imaging With Ga-68 Labeled F(ab') 2- Trastuzumab
NCT ID: NCT00613847
Last Updated: 2020-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
17 participants
INTERVENTIONAL
2006-10-31
2013-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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1
Patients with invasive solid tumors
PET Imaging with Ga-68 Labeled F(ab') 2- Trastuzumab
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.
2
Patients with advanced solid tumors that express HER2 with tumors that are HER2 1+ by IHC or FISH.
PET Imaging with Ga-68 Labeled F(ab') 2- Trastuzumab
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.
Interventions
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PET Imaging with Ga-68 Labeled F(ab') 2- Trastuzumab
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.
PET Imaging with Ga-68 Labeled F(ab') 2- Trastuzumab
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age ≥ or = to 18 years
* Patients with invasive solid tumors.
* Measurable or evaluable disease
* Patients must have had routine disease staging studies with CT scan, FDG PET/CT scan, bone scan and/or MRI within 8 weeks of enrollment onto this trial
* Karnofsky Performance Score ≥ or = to 60
* Signed informed consent
Exclusion Criteria
* Pregnancy Test to be performed on female patients of childbearing potential within 24hrs before administration of radioactive material.
* Patients with known sensitivity or contraindication to Herceptin.
* Inability to provide written informed consent.
18 Years
ALL
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Jorge Carrasquillo, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan Kettering Cancer Center
New York, New York, United States
Countries
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Related Links
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Memorial Sloan-Kettering Cancer Center
Other Identifiers
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06-090
Identifier Type: -
Identifier Source: org_study_id