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

Not Applicable

Terminated

• Conditions: Renal Cell Carcinoma
• Interventions: Drug: 150-Water; Drug: 62Cu-ethylglyoxal bis; Procedure: Positron Emission Tomography; Drug: Sunitinib

• Registration Number: NCT01502228
• Lead Sponsor: Indiana University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-12-28
• Study First Submitted QC: 2011-12-29
• Study First Posted: 2011-12-30
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Results First Submitted: 2016-11-23
• Results First Submitted QC: 2017-03-01
• Results First Posted: 2017-04-12
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-22
• Last Update Posted: 2019-03-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 14

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
62Cu-ETS PET assessment	Positron Emission Tomography	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
62Cu-ETS PET assessment	150-Water	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
62Cu-ETS PET assessment	62Cu-ethylglyoxal bis	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
62Cu-ETS PET assessment	Sunitinib	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

Primary Outcome Measures

Name	Time	Method
Number of Patients Where 62Cu-ETS PET and 15O-water PET Was Obtained	Baseline	Number of patients who had at least a baseline measurement of 62Cu-ETS PET and 15O-water PET

Secondary Outcome Measures

Name	Time	Method
Maximum Standard Uptake Value (SUV) for Lesion Data	Baseline and 14-28 days after initiation of Sunitinib	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.

Trial Locations

Locations (1)

Indiana University Simon Cancer Center; 🇺🇸 Indianapolis, Indiana, United States