PET/CT Assessment of Tumor Perfusion in Patients With Renal Cell Carcinoma
Overview
- Phase
- Not Applicable
- Intervention
- 150-Water
- Conditions
- Renal Cell Carcinoma
- Sponsor
- Indiana University
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- Number of Patients Where 62Cu-ETS PET and 15O-water PET Was Obtained
- Status
- Terminated
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Investigators
Theodore Logan
Associate Professor of Clinical Medicine
Indiana University
Eligibility Criteria
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)
Arms & Interventions
62Cu-ETS PET assessment
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
Intervention: 150-Water
62Cu-ETS PET assessment
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
Intervention: 62Cu-ethylglyoxal bis
62Cu-ETS PET assessment
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
Intervention: Positron Emission Tomography
62Cu-ETS PET assessment
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
Intervention: Sunitinib
Outcomes
Primary Outcomes
Number of Patients Where 62Cu-ETS PET and 15O-water PET Was Obtained
Time Frame: Baseline
Number of patients who had at least a baseline measurement of 62Cu-ETS PET and 15O-water PET
Secondary Outcomes
- Maximum Standard Uptake Value (SUV) for Lesion Data(Baseline and 14-28 days after initiation of Sunitinib)