GIST Metastatic CancerVARIA-DCE-USNCT02666690
Study of the Intra-patient Variability of the Quantitative Parameters of Tumor Perfusion Evaluated With Ultrasound Contrast
A study testing CEUS (Contrast-enhanced ultrasound) in people with GIST Metastatic Cancer and Breast Metastatic Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- GIST Metastatic Cancer, Breast Metastatic Cancer, Kidney Metastatic Cancer
- What is being tested?
- CEUS (Contrast-enhanced ultrasound)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2011to Oct 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- 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,
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Gustave Roussy Cancer Campus Grand Paris
Villejuif, Val de Marne, 94805
About this study
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.
- Conditions
- GIST Metastatic Cancer, Breast Metastatic Cancer, Kidney Metastatic Cancer, Colon Metastatic Cancer, Rectal Metastatic Cancer
- Being tested
- CEUS (Contrast-enhanced ultrasound)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with metastatic cancer treated with anti angiogenics | Experimental | Not described Receives: Device: CEUS (Contrast-enhanced ultrasound) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%
Measured: Assessed 30 days after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2016 (estimated)
- Study startJul 2011
- Primary completionSep 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GIST Metastatic CancerStudies of the same condition, open and under way.
- More trials run by Gustave Roussy, Cancer Campus, Grand ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02666690
- Sponsor's protocol ID
- 2010-A01527-32
- Other IDs
- 2010/1703
- Acronym
- VARIA-DCE-US
- Status last verified
- Aug 2026
- First submitted
- 3 Aug 2015
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Lassau N, Coiffier B, Faivre L, Benatsou B, Bidault S, Girard E, Asselain B, Pitre-Champagnat S, Koscielny S. Study of Intrapatient Variability and Reproducibility of Quantitative Tumor Perfusion Parameters Evaluated With Dynamic Contrast-Enhanced Ultrasonography. Invest Radiol. 2017 Mar;52(3):148-154. doi: 10.1097/RLI.0000000000000324.
PubMed 28106614
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Intra-patient Variability of the Quantitative Parameters of Tumor Perfusion Evaluated With Ultrasound Contrast
- ClinicalTrials.gov ID
- NCT02666690
- Acronym / sponsor ID
- VARIA-DCE-US / 2010-A01527-32
- Conditions
- GIST Metastatic Cancer, Breast Metastatic Cancer, Kidney Metastatic Cancer, Colon Metastatic Cancer, Rectal Metastatic Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 28 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with metastatic cancer treated with anti angiogenics | Experimental | Device: CEUS (Contrast-enhanced ultrasound) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patient being treated at IGR for metastatic cancer by anti-angiogenic (s) drug (s) in the following indications:
- 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.
- Physiological Age: 18-80 years
- performance status <2
Key exclusion criteria (11 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Patients with metastatic cancer treated with anti angiogenics |
Primary outcome
Variability of quantitative parameters of Tumor Perfusion Evaluated With Ultrasound Contrast
Time frame: 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%
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Results publication: PubMed 28106614Lassau N, Coiffier B, Faivre L, Benatsou B, Bidault S, Girard E, Asselain B, Pitre-Champagnat S, Koscielny S. Study of Intrapatient Variability and Reproducibility of Quantitative Tumor Perfusion Parameters Evaluated With Dynamic Contrast-Enhanced Ultrasonography. Invest Radiol. 2017 Mar;52(3):148-154. doi: 10.1097/RLI.0000000000000324.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CEUS (Contrast-enhanced ultrasound) in people with GIST Metastatic Cancer and Breast Metastatic Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variability of quantitative parameters of Tumor Perfusion Evaluated With Ultrasound Contrast (time frame: Assessed 30 days after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02666690, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.