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

• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris (Other)
• Overall Status: Completed
• CT.gov ID: NCT02666690
• Collaborator: (none)
• Enrollment: 59
• Location: 1
• Arm: 1
• Duration (Months): 27
• Patients Per Site Per Month: 2.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
GIST Metastatic Cancer; Breast Metastatic Cancer; Kidney Metastatic Cancer; Colon Metastatic Cancer; Rectal Metastatic Cancer	Device: CEUS (Contrast-enhanced ultrasound)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 59 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Official Title: Study of the Intra-patient Variability of the Quantitative Parameters of Tumor Perfusion Evaluated With Ultrasound Contrast
• Study Start Date: Jul 1, 2011
• Actual Primary Completion Date: Sep 1, 2013
• Actual Study Completion Date: Oct 1, 2013

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Variability of quantitative parameters of Tumor Perfusion Evaluated With Ultrasound Contrast [Assessed 30 days after inclusion]

   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%

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

1. 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)

1. Physiological Age: 18-80 years

2. performance status <2

3. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gustave Roussy Cancer Campus Grand Paris	Villejuif	Val de Marne	France	94805

Sponsors and Collaborators

• Gustave Roussy, Cancer Campus, Grand Paris

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gustave Roussy, Cancer Campus, Grand Paris
• ClinicalTrials.gov Identifier: NCT02666690
• Other Study ID Numbers: 2010-A01527-32; 2010/1703
• First Posted: Jan 28, 2016
• Last Update Posted: Jun 9, 2016
• Last Verified: Jun 1, 2016

• Additional relevant MeSH terms: Neoplasm Metastasis; Neoplasms; Neoplasms, Second Primary

Study Results

No Results Posted as of Jun 9, 2016