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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
Results First Received: November 23, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: No masking;   Primary Purpose: Other
Condition: Renal Cell Carcinoma
Interventions: Drug: 150-Water
Drug: 62Cu-ethylglyoxal bis
Procedure: Positron Emission Tomography
Drug: Sunitinib

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This protocol has 14 patients. Originally, 15 patients were planned, but lack of funding did not allow the final patient to be enrolled.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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 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. Positron Emission Tomography: PET Scan Sunitinib


Participant Flow:   Overall Study
    62Cu-ETS PET Assessment
STARTED   14 
COMPLETED   13 
NOT COMPLETED   1 
Death                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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 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. Positron Emission Tomography: PET Scan Sunitinib


Baseline Measures
   62Cu-ETS PET Assessment 
Overall Participants Analyzed 
[Units: Participants]
 14 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      9  64.3% 
>=65 years      5  35.7% 
Age 
[Units: Years]
Mean (Standard Deviation)
 60.7  (7.26) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      2  14.3% 
Male      12  85.7% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      0   0.0% 
White      14 100.0% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 


  Outcome Measures
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1.  Primary:   Number of Patients Where 62Cu-ETS PET and 15O-water PET Was Obtained   [ Time Frame: Baseline ]

2.  Secondary:   Maximum Standard Uptake Value (SUV) for Lesion Data   [ Time Frame: Baseline and 14-28 days after initiation of Sunitinib ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Theodore Logan
Organization: IndianaU
phone: (317) 948-7449
e-mail: tlogan@iu.edu



Responsible Party: Theodore Logan, Indiana University
ClinicalTrials.gov Identifier: NCT01502228     History of Changes
Other Study ID Numbers: IUCRO-0279
Study First Received: December 28, 2011
Results First Received: November 23, 2016
Last Updated: March 1, 2017