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

This study has been terminated.
(No further funding)
Sponsor:
Information provided by (Responsible Party):
Theodore Logan, Indiana University
ClinicalTrials.gov Identifier:
NCT01502228
First received: December 28, 2011
Last updated: March 1, 2017
Last verified: March 2017
December 28, 2011
March 1, 2017
October 2011
February 2014   (Final data collection date for primary outcome measure)
Number of Patients Where 62Cu-ETS PET and 15O-water PET Was Obtained [ Time Frame: Baseline ]
Number of patients who had at least a baseline measurement of 62Cu-ETS PET and 15O-water PET
Feasibility of recruitment [ Time Frame: 12 months ]
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.
Complete list of historical versions of study NCT01502228 on ClinicalTrials.gov Archive Site
Maximum Standard Uptake Value (SUV) for Lesion Data [ Time Frame: Baseline and 14-28 days after initiation of Sunitinib ]
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.
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: No masking
Primary Purpose: Other
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
    Other Name: Seimens Biograph 64 TruePoint system
  • Drug: Sunitinib
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
  • Drug: Sunitinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
14
February 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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01502228
IUCRO-0279
Yes
Not Provided
No
Not Provided
Theodore Logan, 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
March 2017

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