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

Indiana University14 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Renal Cell Carcinoma

Interventions

150-WaterDRUG

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.

62Cu-ethylglyoxal bisDRUG

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.

Positron Emission TomographyPROCEDURE

PET Scan

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Indiana University Simon Cancer Center

Indianapolis, Indiana, United States

Outcomes

Primary Outcomes

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

Time frame: Baseline

Secondary Outcomes

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.

Time frame: Baseline and 14-28 days after initiation of Sunitinib

Data from ClinicalTrials.gov

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