Neoplasms

All Conditions

Rare Diseases

Glioblastoma

Glioma

Astrocytoma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Participants with suspected Glioblastoma Multiforme undergo CT perfusion prior to surgery or biopsy.

The CT perfusion scan will be performed on a multi-detector CT scanner at the time of routine preoperative neuronavigation imaging. A non-contrast CT head scan will be acquired to localize the tumour. Four 5 mm thick slices will be selected at the level of the tumour. Multiple images will be acquired at each levels starting 5 sec after the injection of 50 cc of non-ionic iodinated contrast media at a rate of 4 cc/sec. The acquisition parameters will be 80 kVp and 100 mA. The images will be acquired every second for a total of 110 sec. The post- processing will be performed and parameters will be calculated using regions of interest in the areas of tumour showing the highest perfusion values. Another region of interest will be placed in the contralateral normal looking white matter.

CT Perfusion

Jai Shankar, MD, DM

Jai Shankar, MD,DM

Jai Shankar

High grade cerebral glioma is the most common primary brain tumor in adults and accounts for about 2.5% of all cancer deaths. Brain tumor affects approximately 2300 individuals per year in Canada. Noninvasive accurate and timely diagnosis is imperative.

High grade glioma is an aggressive neoplasm with median survival of 12 months, irrespective of any treatment. The prognosis of these patients can only be decided based on pathology after biopsy or surgery. Conventional imaging techniques, such as routine magnetic resonance imaging(MRI), do not accurately predict the grade of malignancy of cerebral gliomas. Computed tomography(CT) perfusion allows us to study the blood supply to the tumor at the level of capillaries. This information permits determination of aggressiveness of cerebral gliomas at the time of diagnosis.

In a preliminary study of 20 patients with high grade cerebral gliomas, we have shown that CT perfusion can predict survival at the time of diagnosis irrespective of the pathological grade and the treatment received. In the present study, we would like to extend our preliminary findings in larger group of patients to ensure that this technique is indeed robust. If our hypothesis was supported by our study, we will be able to subselect patients based on initial imaging for more aggressive treatment. In patients with shorter survival, the perfusion parameters may help in identifying new therapeutic targets (e.g., anti-angiogenic agents) that may help in the treatment of these patients.

Purpose of the research: Evaluate the utility of the non-invasive imaging tool of computed tomography (CT) perfusion in preoperative prognostication of high grade cerebral gliomas.

Background information: Brain tumour affects approximately 2300 individuals per year in Canada. High grade glioma is the most common primary brain tumour in adults and accounts for approximately 2.5% of all cancer deaths. The real incidence of high grade glioma in the country is not known, but it affects approximately 2 per 100,000 people per year in Nova Scotia. Non-invasive, accurate and timely diagnosis is imperative.

High grade glioma is an aggressive neoplasm, and the median survival of affected patients is 12 months, irrespective of any form of treatment. The prognosis of these patients can only be determined on pathology after biopsy or surgery. Conventional imaging techniques such as as magnetic resonance imaging(MRI) alone do not help in predicting the level of malignancy of cerebral gliomas. Formation of new blood vessels plays a central role in the growth and spread of tumours. The advanced imaging tool of computed tomography(CT) perfusion can be used to study blood supply to the tumor at the level of capillaries. This information permits determination of aggressiveness of cerebral gliomas at the time of diagnosis.

To direct better and aggressive care in patients with high grade cerebral glioma, it is important to identify patients whose life expectancy could be relatively longer. The two high grades of gliomas have been grouped together in the literature for both treatment and prognosis. There are only a few studies that have addressed the differentiation of the two higher grades of gliomas. Some of these are our own preliminary studies. In a preliminary study of 20 such patients,investigators have shown that CT perfusion can predict survival, irrespective of the pathological grade and treatement received. In the present study, investigators would like to extend our preliminary findings in a larger group of patients to ensure that this technique is indeed robust. In patients with shorter survival, the perfusion parameters may help in identifying new therapeutic targets (e.g., anti-angiogenic agents) that may help in the treatment of these patients.

Both CT and MR perfusion studies can be used to assess the blood supply of brain tumors. MR perfusion is limited in terms of absolute quantification of the perfusion parameters due to the non-linear relationship between the concentration of contrast material and the signal intensity change. MR perfusion studies also require two bolus injections of contrast agents. CT perfusion is a widely available and reliable technique which can give absolute quantification of perfusion parameters with a single acquisition and single bolus of a contrast agent.

Hypothesis- CT perfusion in high grade cerebral gliomas can predict survival irrespective of the pathological grade and irrespective of the treatment given.

Specific objectives: Conduct a prospective study in a larger cohort of patients with high grade cerebral gliomas to assess the utility of CT perfusion and compare this with demographic factors, tumour grade and treatment for estimating prognosis.

Research design: This prospective cohort study will be done over a period of 2 years at QE II Health Sciences Centre, Infirmary Site. All patients, presenting with a newly detected brain lesion likely to be high grade cerebral glioma either on CT or MRI of the brain, will be asked to participate in this study. Pregnant patients or those with impaired renal function will be excluded from the study. Informed consent will be obtained.

Approximately 100 new patients with cerebral glioma present to our brain tumour clinic every year. Our intent is to recruit at least 50 patients with high grade cerebral glioma each year for 2 consecutive years. Each patient will undergo a single CT perfusion scan before undergoing any biopsy or surgical resection.

CT perfusion technique- The CT perfusion scan will be performed on a 128 slice multi-detector CT scanner (Somatom Definition Flash, Siemens). CT perfusion imaging will be performed at the time of routine preoperative neuronavigation imaging. A non-contrast CT head scan will be acquired to localize the tumour before obtaining a perfusion scan. Four 5 mm thick slices with matrix size of 512x512 will be selected at the level of the tumour. Multiple images will be acquired at each levels starting 5 sec after the injection of 50 cc of non-ionic iodinated contrast media (Omnipaque 300) at a rate of 4 cc/sec. The acquisition parameters will be 80 kVp and 100 mA. The images will be acquired every second for a total of 110 sec. The images will be sent to a separate post-processing work station and the post- processing will be performed using the CT perfusion software (Siemens). Two CT perfusion parameters (cerebral blood volume and permeability surface area product) will be calculated using multiple regions of interest in the areas of tumour showing the highest perfusion values. Another region of interest will be placed in the contralateral normal looking white matter.

The patient will undergo biopsy or surgery and histopathological examination of the tissue as per standard of care in our hospital. The perfusion parameters will be correlated with the grade of glioma on pathology. The patient will receive adjuvant treatment as per the institutional standard of care and will be followed clinically as per standard of care. The perfusion parameters will be then correlated with the survival of these patients.

Data analysis- Perfusion parameters will be compared between glioma and normal brain tissue and between different grades of gliomas using a Student 2-sample test. A Cox regression analysis with proportional hazards will be used to determine the relationship between overall survival and perfusion parameters. Kaplan-Meier survival curves will be drawn to demonstrate the relationship between perfusion parameters and overall survival in patients. A p value of less than 0.05 will be considered statistically significant.

Expectations and Relevance of the proposed research

* CT perfusion will help in preoperative characterization of high grade cerebral gliomas and their level of aggressiveness.
* Perfusion parameters will help in predicting the prognosis(irrespective of grade of tumour and treatment given) of the patients with high grade cerebral glioma. This may help in targeting aggressive therapy to patients with predicted longer survival.
* In patients with predicted shorter survival, the perfusion parameters may direct future research on new therapeutic targets.

Possible pitfalls and possible solutions:

1. Radiation exposure from CT perfusion- These patients undergo radiotherapy as part of their treatment, which will have significantly higher radiation dose compared to CT perfusion. Radiation dose from CT perfusion is equivalent to that of 2 head CT scans.
2. Potential kidney toxicity of iodinated dye- Only 50 cc of CT dye will be used, which is smaller compared to the regular dose for enhanced CT scan. Patients with compromised renal function will be excluded from our study.

CT Perfusion in the Prognostication of Cerebral High Grade Glioma

Associate Professor of Diagnostic Radiology

Respiratory Tract (Lung and Bronchial) Diseases

Adenocarcinoma

Adenocarcinoma of Lung

Carcinoma

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Adenocarcinoma

Antineoplastic Agents

All Drugs and Chemicals

Carboplatin

Pemetrexed

Endostar protein

Angiogenesis Inhibitors

Growth Inhibitors

CT Perfusion Imaging(CTPI) at D0, D21 of the first cycle、D6, D14 of the second cycle, measure blood flow ( BF ), blood volume ( BV ), mean transit time ( MTT ), start time ( TTS ), time to peak ( TTP ), Patlak blood volume ( pBV ), vascular permeability etc. before/after tumor tissue treatment.

CT Perfusion Imaging(CTPI) at D0，D6, D14, D21 of the first period, measure blood flow ( BF ), blood volume ( BV ), mean transit time ( MTT ), start time ( TTS ), time to peak ( TTP ), Patlak blood volume ( pBV ), vascular permeability etc. before/after tumor tissue treatment.

Endostar TM 7.5mg/m2,intravenous drip, Day 1to Day 10;Pemetrexed 500mg/m2, intravenous drip, Day 6; Carboplatin AUC=5,intravenous drip, Day 6; 21 days as a cycle, 4 cycles in all.

endostar

You Lu, MD

Meijuan Huang, MD

To evaluate the change of blood perfusion before/after the use of Endostar, discuss the time sequence of Endostar TM in treating advanced lung adenocarcinoma in normalization window period.

The Use of CT Perfusion to Determine the Normalization Window Period in the Treatment of Advanced Primary Lung Adenocarcinoma With Endostar

Simcere Pharmaceutical Co., Ltd

Digestive System Diseases

Carcinoma, Hepatocellular

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Xenetix-CT perfusion imaging

Hatem Alkadhi

The purpose of this study is to prospectively determine the diagnostic value of Xenetix-CT perfusion for the discrimination between well-differentiated hepatocellular carcinomas (HCC) and poorly/moderately differentiated HCC, in histo-pathologically proven HCC, and with the aim to cover the entire liver.

Hepatic Xenetix-CT Perfusion

Diagnostic Contribution of XENETIX® CT PERFUSION in Pre-therapeutical Assessment of Hepatocellular Carcinoma

The mean level of each CT perfusion parameter was compared between well differentiated and moderately/poorly differentiated lesions according to WHO classification evaluated off-site.

The mean level of each CT perfusion parameter was compared between well differentiated and moderately/poorly differentiated lesions according to WHO classification evaluated off-site.

TLP = ALP + PVP

Glutamine synthetase is an immunohistochemistry parameter of hepatocellular carcinoma phenotype.

Glutamine synthetase labelling was quantified and in case of positive quantification, classified in the following categories: 1-10%, 10-50% and \>50%. In case of absence of glutamine synthetase labelling, lesions were classified in the "glutamine synthetase 0%" category.

CD31 is an immunohistochemistry marker of microvessel density. CD31 labelling was quantified and in case of positive quantification, classified in the following categories: 1-10%, 10-50% and \>50%. In case of absence of CD31 labelling, lesions were classified in the "CD31 0%" category.

Guerbet

All included patients receiving at least one injection of Xenetix, regardless of the quantity. This set was used for safety analyses.

Safety Set

All Included Patients

Age, Continuous

Sex: Female, Male

Austria

Korea, Republic of

Switzerland

Germany

Region of Enrollment

Class A

Class B

Class C

Child-Pugh classification of severity of liver disease is evaluated according to the degree of ascites, the plasma concentrations of bilirubin and albumin, the prothrombin time, and the degree of encephalopathy.

* Class A: well compensated disease
* Class B: significant functional compromised
* Class C: decompensated disease

For 7 patients, this score was missing.

Severity of cirrhosis (Child-Pugh score)

Corinne Dubourdieu, PharmD, Head of Clinical Projects and Medical Writing

Among the 90 lesions analyzed for CT perfusion parameters, 47 were well differentiated according to WHO classification.

Well Differentiated Lesions

Among the 90 lesions analyzed, 43 were moderately or poorly differentiated according to WHO classification.

Moderately/Poorly Differentiated Lesions

A total of 77 patients were analyzed for CT perfusion parameters: 38 had lesions assessed as "well differentiated", 42 had lesions assessed as "moderately/poorly differentiated" and 3 had lesions assessed as "well differentiated" and "moderately/poorly differentiated".

Blood Volume (BV) According to Degree of Lesions Differentiation

Among the 90 lesions analyzed, 47 were well differentiated according to WHO classification.

Blood Flow (BF) According to Degree of Lesions Differentiation

Permeability Surface (PS) According to Degree of Lesions Differentiation

Among the 90 lesions analyzed, 47 were well differentiated according to WHO classification

Arterial Liver Perfusion (ALP) According to Degree of Lesions Differentiation

Portal Venous Liver Perfusion (PVP) According to Degree of Lesions Differentiation

Total Liver Perfusion (TLP) According to Degree of Lesions Differentiation

Hepatic Perfusion Index (HPI) According to Degree of Lesions Differentiation

Multinomial logistic regression analyses were performed with each off-site CT perfusion parameters as explicative variables taken alone and each off-site immunohistochemistry categorized parameters as dependent variables.

Absence of glutamine synthetase labelling

Glutamine Synthetase 0%

Quantification of glutamine synthetase labelling from 1 to 10%

Glutamine Synthetase 1-10%

Quantification of glutamine synthetase labelling from 10 to 50%

Glutamine Synthetase 10-50%

Quantification of glutamine synthetase labelling greater than 50%

Glutamine Synthetase >50%

A total of 77 patients were analyzed for CT perfusion and immunohistochemistry parameters. A patient could have several lesions in different groups: 3 patients presented at least 1 lesion in group10-50% and another lesion in group \>50%; 2 patients presented at least 1 lesion in group \>50% and 1 missing data; 2 patients presented missing data.

Blood Volume According to Immunohistochemistry Parameter (Glutamine Synthetase)

CD31 0%

Quantification of CD31 labelling from 1 to 10%

CD31 1-10%

Quantification of CD31 labelling from 10 to 50%

CD31 10-50%

Quantification of CD31 labelling greater than 50%

CD31 >50%

A total of 77 patients were analyzed for CT perfusion and immunohistochemistry parameters. A patient could have several lesions.

Blood Volume According to Immunohistochemistry Parameter (CD31)

Blood Flow According to Immunohistochemistry Parameter (Glutamine Synthetase)

Blood Flow According to Immunohistochemistry Parameter (CD31)

Permeability Surface According to Immunohistochemistry Parameter (Glutamine Synthetase)

Permeability Surface According to Immunohistochemistry Parameter (CD31)

Xenetix-CT perfusion imaging: Injection of 50 ml of Xenetix

Overall Study

Carcinoma, Non-Small-Cell Lung

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Arm A Procedure

On the first required study visit, subject will undergo one SOC CT scan followed by the research component:

* CTP imaging: Single bed position CTP examination, which includes injection of 30 cc of contrast agent, over the predetermined lesion from clinical scan
* Subject will stand up and walk around, and then lay back down
* CT Perfusion imaging: Second single bed position CTP examination, which includes injection of 30 cc of contrast agent, over the predetermined lesion from their clinical scan

Procedures will be repeated at optional second study visit \~6-8 weeks later.

Arm B Procedure

On the first required study visit, subject will undergo one SOC CT scan followed by the research component:

- CT Perfusion imaging: Single bed position CTP examination, which includes injection of 30 cc of contrast agent, over the predetermined lesion from clinical scan

Procedures will be repeated at optional second study visit \~6-8 weeks later.

Subjects will be examined with a CTP Imaging protocol which comprises repeated CT-scans of the tumor over a period of 50 seconds following the injection of a 30cc bolus of an FDA-approved low osmolar, iodinated CT contrast agent using a 64 row-multidetector row CT unit (LightSpeed VCT, GE Healthcare, Milwaukee, WI). One scan will be acquired every 3 seconds over a 50s period at 100 kV, and 100mA tube current. With this method, a 4cm long segment of the tumor can be analyzed, and 32 images of a slice thickness of 1.25 mm reconstructed simultaneously. Images will be evaluated using standard CT blood flow software (Perfusion 2, AW, GE Health Care, Milwaukee, WI).

Mark A. Socinski, MD

This is an experimental study of the feasibility and efficacy of CT perfusion (CTP) imaging (CT blood flow measurements) in subjects with non-small cell lung cancer.

Drug/Device Information

1) Contrast

30 cc bolus of a low osmolar, iodinated CT contrast agent, which is FDA approved and used in the clinical CT Imaging procedure.

2) Scanner

The 64 row-multidetector row CT unit (LightSpeed VCT, GE Healthcare, Milwaukee, WI) is FDA approved for clinical CT imaging

Research Design and Methods

1) Primary Endpoint

1. Diagnostic yield of tumor perfusion measurements using a contrast assisted computed tomography technique.

2) Secondary Endpoints

1. Reproducibility of tumor blood flow estimates derived by CT.
2. Assessment of the association between tumor vascularity responses after two cycles of chemotherapy and subsequent best tumor response according to standard anatomic response evaluation criteria (RECIST).
3. Predictive value of tumor blood flow for patient survival, compared to the predictive power of tumor size determinations.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
CT Perfusion in the Prognostication of Cerebral High Grade Glioma	NCT01923922	Glioblastoma Mu...	CT Perfusion	15 Years -	Nova Scotia Health Authority
The Use of CT Perfusion to Determine the Normalization Window Period in the Treatment of Advanced Primary Lung Adenocarcinoma With Endostar	NCT01564329	Advanced Primar...	endostar	18 Years - 70 Years	Simcere Pharmaceutical Co., Ltd
Hepatic Xenetix-CT Perfusion	NCT01639703	Hepatocellular ...	Xenetix-CT perf...	18 Years -	Guerbet
Computed Tomography (CT) Perfusion Imaging of Lung Cancer	NCT00905801	Carcinoma, Non ...	CT Perfusion	18 Years -	University of Pittsburgh
CT Perfusion in the Prognostication of Cerebral High Grade Glioma	NCT01923922	Glioblastoma Mu...	CT Perfusion	15 Years -	Nova Scotia Health Authority
Computed Tomography (CT) Perfusion Imaging of Lung Cancer	NCT00905801	Carcinoma, Non ...	CT Perfusion	18 Years -	University of Pittsburgh
The Use of CT Perfusion to Determine the Normalization Window Period in the Treatment of Advanced Primary Lung Adenocarcinoma With Endostar	NCT01564329	Advanced Primar...	endostar	18 Years - 70 Years	Simcere Pharmaceutical Co., Ltd
Computed Tomography (CT) Perfusion Imaging of Lung Cancer	NCT00905801	Carcinoma, Non ...	CT Perfusion	18 Years -	University of Pittsburgh
Hepatic Xenetix-CT Perfusion	NCT01639703	Hepatocellular ...	Xenetix-CT perf...	18 Years -	Guerbet

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