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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT01502228
First received: December 28, 2011
Last updated: September 10, 2014
Last verified: September 2014

December 28, 2011
September 10, 2014
October 2011
February 2014   (final data collection date for primary outcome measure)
Feasibility of recruitment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01502228 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
PET/CT Assessment of Tumor Perfusion in Patients With Renal Cell Carcinoma
PET/CT Assessment of Tumor Perfusion in Patients With Renal Cell Carcinoma

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.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Renal Cell Carcinoma
  • 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.
  • Drug: 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
Experimental: 62Cu-ETS PET assessment
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
Interventions:
  • Drug: 150-Water
  • Drug: 62Cu-ethylglyoxal bis
  • Procedure: Positron Emission Tomography
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
15
September 2014
February 2014   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01502228
IUCRO-0279
Yes
Indiana University
Indiana University
Not Provided
Principal Investigator: Fletcher James, M.D. Indiana University, Radiology
Principal Investigator: Theodore Logan, M.D. Indiana University, Dept. Medicine (Hem/Onc)
Indiana University
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP