Ultrasound in Assessing Antiangiogenic Treatment in Patients With Advanced Kidney Cancer

NCT01105364 | Unknown

• 5 other identifiers: INCA-CIT07-FB-CREINCDR0000669914INCA-RECF0653-02EUDRACT-2007-005627-15PFIZER-INCA-CIT07-FB-CREIN
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Diagnostic procedures, such as contrast-enhanced ultrasound, may help measure a patient's response to treatment with drugs such as sunitinib malate, sorafenib tosylate, or bevacizumab, and allow doctors to plan better treatment. PURPOSE: This clinical trial is studying ultrasonography in assessing antiangiogenic treatment in patients with advanced kidney cancer.

Conditions

Kidney Cancer; Metastatic Cancer

Keywords

recurrent renal cell cancer; stage IV renal cell cancer; liver metastases

Outcome Measures

Primary Outcomes (8)

• Lesion size (main diameter)

• Arrival time within lesion

• Time-to-peak

• β parameter from enhancement curve

• Density of microvessels at peak enhancement

• Enhancement ratio between the lesion and the surrounding parenchyma at peak value

• Determination of necrotic and viable volume

• Tumoral response determined by RECIST criteria

Secondary Outcomes (4)

• Time to progression

• Global survey

• Tolerance to antiangiogenic treatments

• Objective response for non-target lesions

Interventions

antiangiogenesis therapy DRUG

stabilized sulphur hexafluoride microbubble-based contrast agent DRUG

imaging biomarker analysis OTHER

pharmacological study OTHER

computed tomography PROCEDURE

magnetic resonance imaging PROCEDURE

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Diagnosis of advanced renal cancer * Planning to receive antiangiogenic treatment * Detection of a target hepatic metastasis that is visible, located, and sized with conventional sonography and CT scan and/or MRI PATIENT CHARACTERISTICS: * No active cardiac disease * No severe arterial hypertension PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute, France: lead

Study Sites (1)

Centre Hospitalier Universitaire Bretonneau de Tours

Tours, 37044, France

RECRUITING

MeSH Terms

Conditions

Kidney Neoplasms; Neoplasm Metastasis; Carcinoma, Renal Cell

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• F. Bruyere, MD

  Centre Hospitalier Universitaire Bretonneau de Tours

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Purpose: DIAGNOSTIC
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: April 15, 2010
• First Posted: April 16, 2010
• Study Start: December 1, 2007
• Primary Completion: March 1, 2012
• Last Updated: August 12, 2013

Record last verified: 2011-09

Locations

FR (1)