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


N/A
18 Years
N/A
Open (Enrolling)
Both
Renal Cell Carcinoma

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Trial Information

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


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)

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Feasibility of recruitment

Outcome Description:

Recruitment will be assessed by examining number approached, number refusing and number enrolling into the trial and how many subjects can be enrolled per month.No formal statistical analysis will be performed.

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

Fletcher James, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Indiana University, Radiology

Authority:

United States: Food and Drug Administration

Study ID:

IUCRO-0279

NCT ID:

NCT01502228

Start Date:

October 2011

Completion Date:

September 2014

Related Keywords:

  • Renal Cell Carcinoma
  • Carcinoma
  • Carcinoma, Renal Cell

Name

Location
Indiana University Simon Cancer Center Indianapolis, Indiana  46202