PET/CT Assessment of Tumor Perfusion in Patients With Renal Cell Carcinoma
This study is currently recruiting participants.
Verified November 2012 by Indiana University
Sponsor:
Indiana University
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT01502228
First received: December 28, 2011
Last updated: November 28, 2012
Last verified: November 2012
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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 |
| Estimated Primary Completion Date: | September 2013 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01502228
Contacts
| Contact: Theodore F Logan, M.D. | 317-944-0920 | tlogan@iupui.edu |
| Contact: Sheila Dropcho, R.N. | 317-278-4191 | sdropcho@iupui.edu |
Locations
| United States, Indiana | |
| Indiana University Simon Cancer Center | Recruiting |
| Indianapolis, Indiana, United States, 46202 | |
| Contact: Sheila Dropcho, R.N. 317-278-4191 sdropcho@iupui.edu | |
| Contact: Theodore Logan, MD 317-278-7576 tlogan@iupui.edu | |
| Principal Investigator: James Fletcher, M.D. | |
| Sub-Investigator: Theodore Logan, M.D. | |
| Sub-Investigator: Mark Green, Ph.D. | |
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: | November 28, 2012 |
| Health Authority: | United States: Food and Drug Administration |
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 |
ClinicalTrials.gov processed this record on May 23, 2013