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Completed

NCT Number: NCT02666690

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

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gustave Roussy Cancer Campus Grand Paris

Villejuif, Val de Marne, 94805, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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%

Sponsors and collaborators

Lead sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Other

Registry information

Acronym: VARIA-DCE-US

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jan 28, 2016
Registry last updated
Jun 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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