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

NCT01502228 | Terminated Results DMC

• 1 other identifier: IUCRO-0279
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline

Secondary Outcomes (1)

• Maximum Standard Uptake Value (SUV) for Lesion Data

  Baseline and 14-28 days after initiation of Sunitinib

Study Arms (1)

62Cu-ETS PET assessment

EXPERIMENTAL

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; Drug: 62Cu-ethylglyoxal bis; Procedure: Positron Emission Tomography; Drug: Sunitinib

Interventions

150-Water 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-ETS PET assessment

62Cu-ethylglyoxal bis 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.

62Cu-ETS PET assessment

Positron Emission Tomography PROCEDURE

PET Scan

Also known as: Seimens Biograph 64 TruePoint system

62Cu-ETS PET assessment

Sunitinib DRUG

62Cu-ETS PET assessment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Related Links

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

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Magnetic Resonance Spectroscopy; Sunitinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Dr. Theodore Logan
• Organization: IndianaU

tlogan@iu.edu

(317) 948-7449

Study Officials

• James Fletcher, M.D.

  Indiana University, Radiology

  PRINCIPAL INVESTIGATOR

• Theodore Logan, M.D.

  Indiana University, Dept. Medicine (Hem/Onc)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical Medicine

Study Record Dates

• First Submitted: December 28, 2011
• First Posted: December 30, 2011
• Study Start: October 1, 2011
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: March 5, 2019
• Results First Posted: April 12, 2017

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)