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
  Purpose

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 Intervention
Renal Cell Carcinoma
Drug: 150-Water
Drug: 62Cu-ethylglyoxal bis
Procedure: Positron Emission Tomography

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: PET/CT Assessment of Tumor Perfusion in Patients With Renal Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 15
Study Start Date: October 2011
Estimated Study Completion Date: September 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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)
  More Information

Additional Information:
No publications provided

Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT01502228     History of Changes
Other Study ID Numbers: IUCRO-0279
Study First Received: December 28, 2011
Last Updated: September 10, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Adenocarcinoma
Kidney Diseases
Kidney Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms

ClinicalTrials.gov processed this record on October 22, 2014