Solid Tumors
Conditions
Keywords
PET Scan, Invasive Solid Tumors
Brief summary
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.
Interventions
RADIATIONPET 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.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Registered patient at MSKCC * 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
* Claustrophobia/pain or any other disability 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. * Patients with known sensitivity or contraindication to Herceptin. * Inability to provide written informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the safety & feasibility of PET imaging with radiolabeled 68Ga-F(ab')2-trastuzumab fragments in pts w invasive solid tumors; by using the organ/tissue & body rt dosimetry inform following i.v. injection of 68Ga-F(ab')2-trastuzumab fragments (HERScan) | conclusion of study |
Secondary
| Measure | Time frame |
|---|---|
| determine the organ/tissue and tumor uptake and localization following i.v. injection of 68Ga-F(ab')2-trastuzumab fragments. | conclusion of study |
| An exploratory objective will be to serially determine tumor uptake of 68Ga-F(ab')2-trastuzumab fragments in a subset of patients with positive scans. | conclusion of study |
Countries
United States
Outcome results
None listed