Neoplasms

All Conditions

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Non randomised study

Sonovue 4,8 ml intravenous administration, in 1 bolus, during the EUS examination

An intravenous 4.8 ml SonoVue® bolus injection was administered to each patient during the procedure

SonoVue®

Rodica Gincul, MD

Bertrand Napoleon, MD

Ductal adenocarcinoma is the most frequent pancreatic solid lesion and the most common tumor of the pancreas. Given its poor prognosis and the major therapeutic consequences, the discrimination between PA and other pancreatic solid lesions is mandatory. EUS is admitted as the most sensitive imaging procedure for the detection and characterization of pancreatic tumors \[1-3\]. Nevertheless it remains difficult to differentiate, on morphological features, PA from other solid masses. For 15 years, endoscopic ultrasound fine needle aspiration (EUS-FNA) has demonstrated its efficiency for tissue sampling and cyto-histologic diagnosis of PA. However, the negative predictive value (NPV) for the diagnosis of pancreatic adenocarcinoma (PA) remains low (30-70%) in the published prospective series \[4\]. So, in case of negative result, the choice between surgery and follow-up remains difficult. Additional criteria to get the decision are then warranted.

The assessment of pancreatic tumor enhancement using ultrasound contrast agents (UCAs) in real time with imaging specific methods seems useful to improve their characterization \[4-8\] either by contrast-enhanced EUS (CE-EUS) or, more recently, by contrast-enhanced harmonic EUS (CH-EUS).

The aims of this prospective multicenter study is:

1. to compare the NPV of contrast-enhanced endoscopic ultrasound (CH-EUS) and EUS-FNA for the diagnosis of PA;
2. to assess the intra- and inter-observer concordances of CH-EUS for the diagnosis of PA.

100 patients with a solid pancreatic mass of indeterminate origin must be prospectively included in 3 French centers Exclusion criteria: presence of a cystic component greater than 25 % of the total volume of the lesion, pregnancy, lactation, age \<18 years, and usual contraindications to SonoVue® injection.

All EUS procedure will be performed by 5 experienced endosonographers as follows:

1. Conventional gray-scale B-mode and conventional power Doppler EUS to assess the EUS characteristics of the pancreatic lesion (localization, size, echogenicity, cystic component), the aspect of the surrounding parenchyma as well as the presence of proximal duct dilation, vessels infiltration, and collateral veins; tumor and nodes (uTN) staging. A systematic video of the 2 modes will be recorded.
2. CH-EUS will be performed to assess the microvascularization of the lesion and of the surrounding parenchyma: the echoendoscope will be placed in front of the pancreatic lesion and the contrast-specific mode will be engaged with simultaneous monitoring by fundamental B mode. A mecanical index (MI) of 0.4 will be chose based on previous studies \[4-6\]. An intravenous 4.8 ml SonoVue® bolus injection will be administrated through an antecubital vein, using a 20 Gauges catheter, followed by 20 ml saline flush. Examination of pancreatic lesion will be evaluated in real time and a video of each examination will be record and store. The examination lasted up to 3 minutes after SonoVue® injection to ensure full examination of the lesion in arterial (hyper echogenicity of the aorta, superior mesenteric, hepatic or splenic arteries) and venous phases (hyper echogenicity of the splenic-mesenteric-portal vessels). The pancreatic lesion enhancement pattern will be compare to the adjacent pancreatic parenchyma. We differentiated 3 patterns: hypo-, iso- or hyperenhancement. The operator classified the lesion as pancreatic adenocarcinoma (PA) or non PA. Based on previous pilot studies, lesion in hypoenhancement consider as PA while lesion in hyper or isoenhancement as non-PA \[4-6\]. In case of tumors with mixed pattern the lesion was considered as PA if a significant area (\>10% of the surface) is in hypoenhancement.
3. EUS-FNA: a specimen will be obtain from all lesions using a 22 Gauge needle. Final diagnosis will be based on pathological findings obtained either surgically or by EUS-FNA. In the absence of histological evidence, follow-up (F-U) of patients for 12 months will be carried out. The diagnosis of PA ruled out if no sign of malignancy (disease regression or absence of disease progression) present at the end of F-U.
4. Images reviewing: at the end of the study an anonymous digital video recording of each procedure including B mode, power Doppler mode and CHE mode will be performed.

Statistical analysis. The McNemar test will be use to compare the CH-EUS performance for the diagnosis of PA to EUS-FNA and final diagnosis. Sensitivity (Se), specificity (Spe), predictive positive value (PPV), negative predictive value (NPV) and accuracy with 95% confidence intervals (95%CI) will be calculate. A p value of 0.05 considered statistically significant. Intra- and interobserver agreements of CH-EUS for the diagnosis of PA will assess using kappa statistics and associated 95% CI. Depending on Kappa values, agreement will considered as minor (0.01-0.20), fair (0.21-0.40), moderate (0.41-0.60), high (0.61-0.80), or almost perfect (0.81-1.00), beyond chance.

Contrast-harmonic Endoscopic Ultrasound (CH-EUS) for the Diagnosis of Pancreatic Adenocarcinoma

Contrast-harmonic Endoscopic Ultrasound (CH-EUS) for the Diagnosis of Pancreatic Adenocarcinoma: Results of the First Multicenter Prospective Study With Intra- and Interobserver Concordances Evaluation

To evaluate the NPV of CH-EUS for the diagnosis of PA to EUS-FNA and final diagnosis

an anonymous digital video recording of each procedure including B mode, power Doppler mode and CHE mode was created. A 2-days joint work session was organized with 7 endosonographers: the 5 senior endoscopists who had performed the examinations and 2 juniors. To harmonizing the interpretation a short teaching session was done with some cases not included in the series. The different types of enhancement of solid pancreatic masses histologically proven (PA, benign and malignant NET, pancreatic metastases, and focal mass of CP) were shown. During day 1 the 7 operators reviewed independently and in a random order all 100 anonymous videotapes. One senior and 1 junior reviewed all videotapes a second time in a different random order. Each observer had to independently classify the lesion as PA or not. During day 2 a joint review was done with the cases where a discrepancy of interpretation has been observed. A final consensus for the diagnosis was proposed if possible.

To evaluate the Se of CH-EUS for the diagnosis of of pancreatic adenocarcinoma (PA) to EUS-FNA and final diagnosis

To evaluate the specificity (Spe) of CH-EUS for the diagnosis of PA to EUS-FNA and final diagnosis

To evaluate the PPV of CH-EUS for the diagnosis of PA to EUS-FNA and final diagnosis

To evaluate the accuracy of CH-EUS for the diagnosis of PA to EUS-FNA and final diagnosis value (PPV)

To compare the accuracy of CH-EUS and EUS-FNA for the diagnosis of PA with 95% confidence intervals (95%CI)

Société Française d'Endoscopie Digestive

Symptoms and General Pathology

Digestive System Diseases

Neoplasm Metastasis

Liver Neoplasms

Neoplastic Processes

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Hematinics

All Drugs and Chemicals

Liver Extracts

Contrast-enhanced intraoperative ultrasound

Once the patient is included in the study, a staging procedure is performed in three stages before hepatic metastases treatment:

Step # 1 preoperative (maximum 8 weeks before surgery Steps # 2 and # 3 intraoperative performed by the same surgeon in 2 stages

EVRARD Serge, PU-PH

Hypothesis: Use of contrast ultrasound showed interesting results, which can increase ultrasonography sensitivity performed during surgery in the evaluation of operable liver metastases.

This study is a two-stage phase II multicenter study (Simon's two-stage).

Ultrasound Liver Intraoperative Imaging With SonoVue®

Clinical Utility of Contrast-enhanced Intraoperative Ultrasound in Surgery of Colorectal Liver Metastases. Phase II Clinical Trial.

The clinical utility will be evaluated in terms of justified modification of the surgical procedure following contrast-enhanced intra-operative ultrasound (CE-IOUS), compared to the surgical procedure following conventional intra-operative ultrasound. For each patient, we will consider CE-IOUS to be clinically useful:

* if the surgical procedure envisaged at the end of the CE-IOUS is different from the surgical procedure envisaged at the end of the conventional ultrasound
* and if the surgical procedure envisaged at the end of the CE-IOUS is justified We reported the percentage of patients for whom there was a modified and justified surgical gesture following CE-IOUS.

The primary endpoint will be assessed in the subgroup of patients who received preoperative chemotherapy. As for the primary outcome, the clinical utility is evaluated in terms of justified modification of the surgical gesture envisaged following CE-IOUS, compared to the surgical gesture envisaged following a conventional intraoperative ultrasound.

We reported the percentage of patients for whom there was a modified and justified surgical gesture following CE-IOUS in the subgroup of patients who received preoperative chemotherapy.

Detection of malignant lesions by CE-IOUS in chemotherapy-free patients within 3 post-operative months. The detection rate is defined as the proportion of malignant lesions for which there is concordance between the diagnosis established by CE-IOUS and the reference examination.

Description of technical arrangements for the CE-IOUS duration. The length of time during which contrast injection was useable.

Characterisation rate for focal liver lesions: the proportion of lesions whose nature on CE-IOUS is identical to the nature of the lesions defined by the reference examinations among all the lesions seen on CE-IOUS (malignant and benign)

Institut Bergonié

Contrast-enhanced intraoperative ultrasound

Contrast-enhanced intraoperative ultrasound: Once the patient is included in the study, a staging procedure is performed in three stages before hepatic metastases treatment:

Step # 1 preoperative (maximum 8 weeks before surgery Steps # 2 and # 3 intraoperative performed by the same surgeon in 2 stages

Contrast-enhanced Intraoperative Ultrasound

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

Right Colon

Left Colon

Transverse Colon

Rectum

Cancer localization

Synchronous

Metachronous

Liver metastases

Derek Dinart

Contrast-enhanced intraoperative ultrasound

Contrast-enhanced intraoperative ultrasound: Once the patient is included in the study, a staging procedure is performed in three stages before hepatic metastases treatment:

Step # 1 preoperative (maximum 8 weeks before surgery Steps # 2 and # 3 intraoperative performed by the same surgeon in 2 stages. Step #2 intraoperative ultrasound and step #3 Contrast-enhanced intraoperative ultrasound

We used a 2-stage Simon's design with the following assumptions:

* maximum tolerated futility rate: 5%,
* expected minimum utility rate: 15%,
* Type I error of 10%,
* power of 85%. Thus, 52 eligible and evaluable patients were required (25 in the first stage). First stage: stop, if CE-IOUS is not deemed clinically useful for at least one patient (4.0%).

Second stage: CE-IOUS clinically useful if the planned surgical procedure is modified and justified for 5 or more patients (9.6%).

Clinical Utility of Intraoperative Contrast Ultrasound in the Surgery of Colorectal Cancer Liver Metastases.

Subgroup of patients with preoperative chemotherapy

Clinical Utility of CE-IOUS in Subgroup of Patients Who Received Preoperative Chemotherapy

There were 22 (40.7%) out of 54 chemotherapy-free patients within 3 post-operative months

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Contrast-harmonic Endoscopic Ultrasound (CH-EUS) for the Diagnosis of Pancreatic Adenocarcinoma	NCT01765036	Pancreatic Aden...	SonoVue®	18 Years -	Société Française d'Endoscopie Digestive
Contrast-harmonic Endoscopic Ultrasound (CH-EUS) for the Diagnosis of Pancreatic Adenocarcinoma	NCT01765036	Pancreatic Aden...	SonoVue®	18 Years -	Société Française d'Endoscopie Digestive
Ultrasound Liver Intraoperative Imaging With SonoVue®	NCT01880554	Liver Metastase...	Contrast-enhanc...	18 Years -	Institut Bergonié
Ultrasound Liver Intraoperative Imaging With SonoVue®	NCT01880554	Liver Metastase...	Contrast-enhanc...	18 Years -	Institut Bergonié

Spots Global Cancer Trial Database for sonovue®

Every month we try and update this database with for sonovue® cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for sonovue®

Every month we try and update this database with for sonovue® cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for sonovue® cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.