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

Indiana University

Status: Terminated

Conditions: Renal Cell Carcinoma

Treatments: Drug: Sunitinib; Drug: 62Cu-ethylglyoxal bis; Procedure: Positron Emission Tomography; Drug: 150-Water

Study type: Interventional

Funder types: Other

Identifiers

NCT01502228

IUCRO-0279

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

62Cu-ETS PET assessment

Experimental group

Description:

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

Treatment:

Procedure: Positron Emission Tomography

Drug: Sunitinib

Drug: 150-Water

Drug: 62Cu-ethylglyoxal bis