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

NCT ID: NCT01502228

Last Updated: 2019-03-05

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2014-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Renal Cell Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

150-Water

Intervention Type DRUG

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

Intervention Type DRUG

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

Intervention Type PROCEDURE

PET Scan

Sunitinib

Intervention Type DRUG

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Positron Emission Tomography

PET Scan

Intervention Type PROCEDURE

Sunitinib

Intervention Type DRUG

Other Intervention Names

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Seimens Biograph 64 TruePoint system

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Indiana University

OTHER

Sponsor Role lead

Responsible Party

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Theodore Logan

Associate Professor of Clinical Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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James Fletcher, M.D.

Role: PRINCIPAL_INVESTIGATOR

Indiana University, Radiology

Theodore Logan, M.D.

Role: PRINCIPAL_INVESTIGATOR

Indiana University, Dept. Medicine (Hem/Onc)

Locations

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Indiana University Simon Cancer Center

Indianapolis, Indiana, United States

Site Status

Countries

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United States

Related Links

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https://www.indianactsi.org

09008-12(1011004283)-PT/CT Assessment of Tumor Perfusion in Patients with RCC

Other Identifiers

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IUCRO-0279

Identifier Type: -

Identifier Source: org_study_id

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