Back to resultsPET/CT Assessment of Tumor Perfusion in Patients With Renal Cell Carcinoma
Primary Purpose
Renal Cell Carcinoma
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
150-Water
62Cu-ethylglyoxal bis
Positron Emission Tomography
Sunitinib
Sponsored by
About this trial
This is an interventional other trial for Renal Cell Carcinoma
Eligibility Criteria
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)
Sites / Locations
- Indiana University Simon Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
62Cu-ETS PET assessment
Arm Description
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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01502228
First Posted
December 28, 2011
Last Updated
February 22, 2019
Sponsor
Indiana University
1. Study Identification
Unique Protocol Identification Number
NCT01502228
Brief Title
PET/CT Assessment of Tumor Perfusion in Patients With Renal Cell Carcinoma
Official Title
PET/CT Assessment of Tumor Perfusion in Patients With Renal Cell Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Terminated
Why Stopped
No further funding
Study Start Date
October 2011 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cell Carcinoma
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
62Cu-ETS PET assessment
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
150-Water
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
62Cu-ethylglyoxal bis
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Positron Emission Tomography
Other Intervention Name(s)
Seimens Biograph 64 TruePoint system
Intervention Description
PET Scan
Intervention Type
Drug
Intervention Name(s)
Sunitinib
Primary Outcome Measure Information:
Title
Number of Patients Where 62Cu-ETS PET and 15O-water PET Was Obtained
Description
Number of patients who had at least a baseline measurement of 62Cu-ETS PET and 15O-water PET
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Maximum Standard Uptake Value (SUV) for Lesion Data
Description
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.
Time Frame
Baseline and 14-28 days after initiation of Sunitinib
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Fletcher, M.D.
Organizational Affiliation
Indiana University, Radiology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Theodore Logan, M.D.
Organizational Affiliation
Indiana University, Dept. Medicine (Hem/Onc)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University Simon Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.indianactsi.org
Description
09008-12(1011004283)-PT/CT Assessment of Tumor Perfusion in Patients with RCC
Learn more about this trial
PET/CT Assessment of Tumor Perfusion in Patients With Renal Cell Carcinoma
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