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

Renal Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01502228
• Other study ID #: IUCRO-0279
• Status: Terminated
• Phase: N/A
• Start date: October 2011
• Est. completion date: February 2014

Study information

• Verified date: February 2019
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Intervention

Drug:
• 150-Water
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 bis
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.

Procedure:
• Positron Emission Tomography
PET Scan

Drug:
• Sunitinib

Locations

Country	Name	City	State
United States	Indiana University Simon Cancer Center	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   09008-12(1011004283)-PT/CT Assessment of Tumor Perfusion in Patients with RCC