Study of the Intra-patient Variability of the Quantitative Parameters of Tumor Perfusion Evaluated With Ultrasound Contrast (VARIA-DCE-US)

RECIST criteria for evaluating tumor response are often inadequate for the evaluation of anti-angiogenic drugs. An evaluation model of tumor perfusion with contrast-enhanced ultrasonography was developed at Gustave Roussy. It assesses the tumor vascular response through the analysis of 7 different parameters. Several studies (four at IGR, involving 117 patients, and a multicenter study involving 400 patients) showed that CEUS allows early evaluation of the effect of anti-angiogenic drugs. Two of these parameters are particularly interesting for the early identification of patients responding (or not) to treatment. Those are area under curve , and area under the wash-out. To further validate the use of these parameters, it is essential to measure and describe the level of their intra-patient variability.

Study Overview

• Status: Completed
• Conditions: GIST Metastatic Cancer; Breast Metastatic Cancer; Kidney Metastatic Cancer; Colon Metastatic Cancer; Rectal Metastatic Cancer
• Intervention / Treatment: Device: CEUS (Contrast-enhanced ultrasound)

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Val de Marne
    • Villejuif, Val de Marne, France, 94805
      • Gustave Roussy Cancer Campus Grand Paris

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patient being treated at IGR for metastatic cancer by anti-angiogenic (s) drug (s) in the following indications:

   • Gastrointestinal sarcoma (GIST)
   • Breast Cancers
   • Kidney Cancers
   • Colorectal Cancers
   • Melanoma

   These anti-angiogenic drugs are used alone or in combination: Bevacizumab (Avastin), imatinib (Gleevec), Sorafenib (Nexavar), sunitinib (Sutent), Everolimus (Afinitor) Temsirolimus (Torisel), ... (non exhaustive list).

2. With at least one clearly identified metastatic tumor lesion (and accessible to ultrasound for acquisition 3 minutes without losing the target), measuring more than 2 cm, less than 50% of the volume is necrotic.

   Metastatic lesions are:

   • Liver (30 patients)
   • Or outside the liver (30 patients)
3. Physiological Age: 18-80 years
4. performance status <2
5. Patient information and signature of informed consent

Exclusion Criteria:

1. Background known hypersensitivity to sulfur hexafluoride or one of the components,
2. recent history of acute coronary syndrome or unstable ischemic heart disease,
3. Acute heart failure, heart failure stage III or IV, or severe rhythm disorders,
4. uncontrolled hypertension or severe pulmonary hypertension,
5. Right-Left Shunt,
6. Respiratory Distress Syndrome,
7. Patient without vascularized tumor (without contrast enhancement)
8. patient whose antiangiogenic has already started,
9. Pregnant woman likely to be or breastfeeding,
10. Persons deprived of liberty or under guardianship,
11. Unable to submit to medical monitoring of the trial for geographical, social or psychological reasons

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with metastatic cancer treated with anti angiogenics	Device: CEUS (Contrast-enhanced ultrasound); Each patient will be performed 2 contrast echocardiography (a pre-prandial - a post-prandial) before the antiangiogenic treatment, at D15 and D30.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Variability of quantitative parameters of Tumor Perfusion Evaluated With Ultrasound Contrast	Demonstrate that for the hepatic metastatic sites and for non hepatic metastatic sites the variability of the measured quantitative parameters on two different perfusion curves is less than 30%	Assessed 30 days after inclusion

Collaborators and Investigators

• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: August 3, 2015
• First Submitted That Met QC Criteria: January 27, 2016
• First Posted (Estimate): January 28, 2016

Study Record Updates

• Last Update Posted (Estimate): June 9, 2016
• Last Update Submitted That Met QC Criteria: June 8, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplastic Processes; Neoplasms; Neoplasm Metastasis; Neoplasms, Second Primary
• Other Study ID Numbers: 2010-A01527-32; 2010/1703 (Other Identifier: CSET number)