Study of the Intra-patient Variability of the Quantitativ... | NCT02666690

Studies
Study of the Intra-patient Variability of the Quantitative Parameters of Tumor Perfusion Evaluated With Ultrasound Contrast

NCT02666690

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Status

Completed

Last Update Posted

Jun 9, 2016Estimated

Enrollment

59Actual

Phase

Not Applicable

Conditions

GIST Metastatic Cancer
Breast Metastatic Cancer
Kidney Metastatic Cancer
Colon Metastatic Cancer
Rectal Metastatic Cancer

Interventions

CEUS (Contrast-enhanced ultrasound)

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
2010/1703	Other Identifier	CSET number

Status Module

Record Verification Date

Jun 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2011

Primary Completion Date

Sep 2013Actual

Completion Date

Oct 2013Actual

First Submitted Date

Aug 3, 2015

First Submission Date that Met QC Criteria

Jan 27, 2016

First Posted Date

Jan 28, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 8, 2016

Last Update Posted Date

Jun 9, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

59Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with metastatic cancer treated with anti angiogenics	Experimental		Device: CEUS (Contrast-enhanced ultrasound)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CEUS (Contrast-enhanced ultrasound)	Device	Each patient will be performed 2 contrast echocardiography (a pre-prandial - a post-prandial) before the antiangiogenic treatment, at D15 and D30.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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).
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)
Physiological Age: 18-80 years
performance status <2
Patient information and signature of informed consent

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided