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

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ClinicalTrials.gov Identifier: NCT01502228
Recruitment Status : Terminated (No further funding)
First Posted : December 30, 2011
Results First Posted : April 12, 2017
Last Update Posted : April 12, 2017
Sponsor:
Information provided by (Responsible Party):
Theodore Logan, Indiana University

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.

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Drug: 150-Water Drug: 62Cu-ethylglyoxal bis Procedure: Positron Emission Tomography Drug: Sunitinib Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: PET/CT Assessment of Tumor Perfusion in Patients With Renal Cell Carcinoma
Study Start Date : October 2011
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drinking Water
U.S. FDA Resources

Arm Intervention/treatment
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
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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01502228


Locations
United States, Indiana
Indiana University Simon Cancer Center
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Investigators
Principal Investigator: Fletcher James, M.D. Indiana University, Radiology
Principal Investigator: Theodore Logan, M.D. Indiana University, Dept. Medicine (Hem/Onc)

Responsible Party: Theodore Logan, Associate Professor of Clinical Medicine, Indiana University
ClinicalTrials.gov Identifier: NCT01502228     History of Changes
Other Study ID Numbers: IUCRO-0279
First Posted: December 30, 2011    Key Record Dates
Results First Posted: April 12, 2017
Last Update Posted: April 12, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Sunitinib
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors