PET/CT Assessment of Tumor Perfusion in Patients With Renal Cell Carcinoma

Study Overview
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Brief Summary
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Given the growing importance of anti-angiogenic therapies in the treatment of metastatic renal carcinoma, it is expected that this trial will establish the preliminary data needed to apply for funding of a larger clinical investigation of the potential role of PET perfusion imaging in management of renal carcinoma, and potentially other cancers.

Official Title
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PET/CT Assessment of Tumor Perfusion in Patients With Renal Cell Carcinoma

Conditions
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Renal Cell Carcinoma

Intervention / Treatment
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* Drug: 150-Water
* Drug: 62Cu-ethylglyoxal bis
* Procedure: Positron Emission Tomography
* Drug: Sunitinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ability to understand and willingness to sign a witnessed, informed consent and authorization for the release of health information. Patients with a diagnosis of relapsed Stage IV renal cell cancer that are medically unresponsive to prior treatment or surgically unresectable and with metastases that fall within the PET/CT field-of-view that can include the heart. Being considered for systemic therapy with Sunitinib Exclusion Criteria: Women who are pregnant, breast-feeding, or of childbearing potential and not using birth control Having no telephone or a reliable way in which study personal can contact them Subjects who are claustrophobic and cannot tolerate imaging procedures Subjects who weigh > 350 lb. (upper weight limit of scanner beds)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 62Cu-ETS PET assessment<br>CT scan for attenuation correction; 15O-water administered by intravenous injection and 6-minute dynamic PET imaging; 62Cu-ETS administered by intravenous injection; Dynamic PET acquisition for 6-minutes; Whole-body PET acquisition from 6-20 minutes post-62Cu-ETS injection | Drug: 150-Water<br>* Patients will be imaged immediately before, and between 14-28 days after initiation of Sunitinib therapy, in the single bed position using the Siemens Biograph 64 TruePoint system located in the clinical facilities of the I.U. Cancer Center. Administer 15O-water at 50 mCi/dose, IV.<br>Drug: 62Cu-ethylglyoxal bis<br>* Imaging with 62Cu-ETS will be done immediately following imaging with 150-water. Patients will be imaged immediately before, and between 14-28 days after, initiation of Sunitinib therapy using the Siemens Biograph 64 TruePoint system located in the clinical facilities of the I.U. Cancer Center. Administer 62Cu-ETS in the range of 20-25 mCi/Dose, IV.<br>Procedure: Positron Emission Tomography<br>* PET Scan<br>* Other names: Seimens Biograph 64 TruePoint system;Drug: Sunitinib<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients Where 62Cu-ETS PET and 15O-water PET Was Obtained | Number of patients who had at least a baseline measurement of 62Cu-ETS PET and 15O-water PET | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Standard Uptake Value (SUV) for Lesion Data | Average values of the magnitude of tumor perfusion before and 14-28 days after initiation of Sunitinib treatment as measured by the maximum standard uptake value for all the lesion data. Standard uptake values were calculated as the ratio of the image derived radioactivity concentration and the whole body concentration of the injected radioactivity tracer. There were 14 patients who had a baseline reading and 12 patients who had a reading after treatment. | Baseline and 14-28 days after initiation of Sunitinib |