Neoplasms

Digestive System Diseases

All Conditions

Symptoms and General Pathology

Colorectal Neoplasms

Body Weight

Neoplasm Metastasis

Liver Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Liver Diseases

Antineoplastic Agents

All Drugs and Chemicals

Hematinics

Bevacizumab

Liver Extracts

Eligible participants in Arm A enrolled in this imaging study will: be older than 18, have metastatic colorectal cancer with at least one hepatic lesion, and be treated with FOLFOX in combination with bevacizumab.

Eligible participants in Arm B enrolled in this imaging study will: be older than 18, must have prior histological documentation of any types of cancer with metastasis to the liver, and must be in stable treatment conditions prior to and between scans.

Participants will receive two (2) dynamic contrast enhanced magnetic resonance imaging (DCE-MRI) prior to chemotherapy and one (1) DCE-MRI after the first cycle of chemotherapy. Participants will be followed for up to 2 years after the initiation of chemotherapy or until disease progression.

DCE-MRI

Mark Rosen, MD, PhD

Larry Dougherty, PhD

Donald Mitchell, MD

Peter J O'Dwyer, MD

Michael D Feldman, MD, PhD

The objectives for this study include:

* Testing a unique way of imaging people with colorectal cancer and other cancers that has spread to the liver using magnetic resonance imaging (MRI);
* Seeing if the MRI process can be used across multiple imaging platforms;
* Determining whether the results of the imaging can be reproduced;
* Reviewing how MRI results relate to cancer response to combination therapy and to clinical endpoints.

This study will investigate the use of projection reconstruction dynamic contrast-enhanced MRI (DCE-MRI) as a surrogate marker of tumor vascularity in patients treated with the antiangiogenic agent bevacizumab. DCE-MRI is gaining popularity as a method to assess the functional response of tumors to agents targeting the vascular endothelial growth factor (VGEF) pathways. DCE-MRI measurements have been proposed as a non-invasive measure of both tumor biologic activity and (in the case of antivascular therapy) early response to treatment. A number of phase I and II studies demonstrate the ability for DCE-MRI to detect perfusion changes associated with tumor biologic response to vascularly targeted agents. It has been suggested that pre-treatment DCE-MRI might identify tumors with high intrinsic perfusion and that these tumors will be more likely to respond to antivascular-based therapies. However, the current use of DCE-MRI in clinical settings is challenging. Trade-offs between spatial coverage, time, and spatial resolution make this technique difficult to implement in human studies and may limit its reliability. The use of projection reconstruction-based acquisition can mitigate the need for these trade-offs and can simultaneously provide high temporal and spatial resolution data for DCE-MRI analysis.

Metastatic Colorectal Cancer: Treatment Response With Dynamic Contrast MRI

Angle Interleaved Projection Reconstruction With K-Space Weighted Image Reconstruction for Dynamic Contrast MRI of Cancer Therapy Response

Pennsylvania Department of Health

American College of Radiology

Carcinoma

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

IV contrast perfusion CT will be performed at baseline and at 1 week after completing treatment. Perfusion imaging is similar to a diagnostic CT except a smaller region is serially imaged post contrast injection with multiple data acquisitions and high temporal resolution.

IV contrast perfusion CT will be performed at baseline and at 1 week after completing treatment. Perfusion imaging is similar to a diagnostic CT except a smaller region is serially imaged post contrast injection with multiple data acquisitions and high temporal resolution

Perfusion Imaging

Steven Thomas

Francois Benard, MD

The high dose per fraction (\>10Gy/fraction) used in Stereotactic Ablative Body Radiotherapy (SABR) has been shown to be more effective at local tumor control than treatments employing more conventional dose fractions. The mechanisms for this are currently under debate. One possible mechanism for this increased effectiveness is that high dose/fraction causes significant vascular damage to the tumor. This study hopes to measure vascular integrity pre and post SABR treatment using kinetic models obtained from dynamic contrast enhanced CT.

Purpose:

The purpose of this study is to determine if high dose per fraction SABR has an impact on the vasculature of both the tumor and of healthy liver tissue.

Hypothesis:

High dose / fraction in HCC patients with tumours \< 5 cm will result in detectable changes to kinetic model parameters derived from dynamic contrast enhanced images.

Objectives:

Primary objective:

To quantify changes in tumor vascular support for patients receiving SABR.

Secondary objectives:

To investigate the correlation between PK derived model liver perfusion parameters and QoL metrics as measured by EORTC QLQ-C30 and FACT-Hep QoL assessments.

Research Methods:

Target population are patients receiving liver SABR for no more than 2 discrete liver tumors with a maximum dimension \<5cm.

Perfusion CT Image Data Post Processing and Analysis. Patient motion will be corrected using deformable registration, fiducial tracking, and RPM breathing traces. Organ ROIs will be added to the perfusion image series by manually translating anatomical planning CT ROIs to the motion-corrected perfusion image series, or by algorithmically deforming planning ROIs. Portal vein and abdominal aorta ROIs will be demarcated.

Analysis will proceed via custom software we have built during related projects. Contrast enhancement time courses will be generated for key structures (i.e., abdominal aorta, portal vein, and gross liver tissues) and used to derive a variety of perfusion map images, such as liver perfusion, mean transit time, arterial fraction, and distribution volume. A distributed parameter model will be preferred for kinetic modeling. Supplementary non-parametric techniques will be used for other parameters of interest (e.g., IAUC, maximum slope).

Images acquired before and after treatment will be registered so that parameter maps can be compared on a per-patient basis. Changes in perfusion parameters will be characterized with special emphasis placed on regional structure and clustering effects. Pre and post parameter maps will be computed near individual-voxel level. Regions of interest (1) within or near tumour and (2) at a low-dose portion of liver will be defined. A distribution of parameters within each ROI will be used to generate estimates of the mean parameters and uncertainty. Estimates of mean parameters and whole distributions will be compared using standard statistical comparisons (t-test and Whitney respectively).

Quality of Life We will evaluate quality of life (QOL) in HCC patients treated with SBRT using EORTC QLQ-C30 and FACT-Hep QOL assessments at baseline, 3, 6, 9 and 12 months. Correlation between perfusion parameter changes and patient outcomes or QOL (second-order analysis) will be applied if statistically significant first-order parameter changes can be detected. Standard correlative measures such as the Pearson product-moment correlation measure will be used to assess statistical significance. As there is currently no data relating liver perfusion to toxicity or quality of life, this study will examine whether a change in liver perfusion is correlated with enhanced or reduced QOL.

Dynamic Contrast Enhanced HCC SABR Liver Study

Dynamic Contrast Enhanced Imaging of Patients Receiving SABR for Unresectable or Medically Inoperable Hepatocellular Carcinoma in BC

To quantify changes in tumor vascular support for patients receiving SABR.

To investigate the correlation between PK derived model liver perfusion parameters and QOL metrics as measured by EORTC QLQ-C30 and FACT-Hep QOL assessments.

University of British Columbia

British Columbia Cancer Agency

Scientific Director, Functional Imaging

Respiratory Tract (Lung and Bronchial) Diseases

Wounds and Injuries

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Lung Injury

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Radiopharmaceuticals

All patients included for treatment with stereotactic radiotherapy for non-small cell lung cancer or lung metastasis will benefit from a pre-therapeutic functional assessment including:

* The standard functional assessment recommended before performing an SBRT.
* A perfusion PET/CT scan

The treatment planning will be carried out in 2 stages:

* First, an anatomical planning will be carried out, blinded to the PET results.
* Then, a functional planning, respecting the standard constraints applied during anatomical planning, but also incorporating a new "functional lung volume" constraint defined by pulmonary PET, will then be carried out.

A follow-up will be carried out for 12 months, including repeated perfusion PET/CT imaging at 3 and 12 months

The radiopharmaceutical used for lung perfusion PET consists in human albumin macroaggregates labeled with Ga-68 (68Ga-MAA). 68Ga- MAA are administrated intravenously.

Pre-therapeutic imaging test

This is a prospective study evaluating the feasibility of treatment planning integrating lung perfusion PET/CT using Ga68-MAA to preserve functional lung areas during stereotactic body radiation therapy (SBRT).

Lung perfusion PET / CT is a new imaging modality based on the use of the same cold molecules as those used for a conventional perfusion lung scan. Similartly, perfusion images are obtained after intravenous administration of human albumin macroaggregates, which are embolized in pulmonary capillaries according to pulmonary blood flow. However, these cold molecules are radiolabeled, not with Technetium99m, but with Gallium68, a ß + isotope, allowing image acquisition with PET technology. The same physiological processes are therefore observed with conventional scintigraphy PET imaging, but PET is an intrinsically superior technique for image acquisition, with greater sensitivity, better spatial and temporal resolutions and the possibility to perform respiratory-gated acquisition, allowing a better definition of the pulmonary functional volumes.

The aim is to evaluate the feasability of functional lung avoidance planification using lung perfusion PET/CT imaging during SBRT.

Patients will benefit from a pre-treatment functional assessment including PET/CT imaging.

The treatment planning will be carried out in 2 stages:

* First, an anatomical planning will be carried out, blinded to the PET results.
* Then, a functional planning, respecting the standard constraints applied during anatomical planning, but also incorporating a new "functional lung volume" constraint defined by PET/CT images, will be carried out.

A follow-up will be carried out for 12 months, including repeated perfusion PET/CT imaging at 3 and 12 months.

Lung Perfusion PET / CT Using Ga68-MAA for Preservation of Lung Function During Stereotactic Pulmonary Radiation Therapy

Lung Perfusion PET / CT Using Gallium68-MMA for Preservation of Lung Function During Stereotactic Pulmonary Radiation Therapy

All collected data that underlie results in a publication

Percentage of patients for whom it is possible to reduce the dose to the functional lung (estimated during the functional planning).

A reduction in the dose to the functional lung will be defined by:

* A decrease of at least 5% in functional lung volume included in V20Gy. or
* A decrease of at least 5% in total relative lung function included in the V20G.

Percentage of activity included in the V20Gy with the anatomical planning and the functional planning.

Percentage of functional lung volume included in the V20Gy with anatomical planning and during functional planning

Pulmonary toxicity defined according to EORTC (European Organisation for Research and Treatment of Cancer) criteria (Common Terminology Criteria for Adverse Events 5.0, EORTC QLQ-C30 : European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire - Cancer module 30) at 3 months

Pulmonary toxicity defined according to EORTC (European Organisation for Research and Treatment of Cancer) criteria (Common Terminology Criteria for Adverse Events 5.0, EORTC QLQ-LC13 :European Organisation for Research and Treatment of Cancer- Quality of Life Questionnaire - Lung Cancer module 13) at 3 months

Pulmonary toxicity defined according to EORTC (European Organisation for Research and Treatment of Cancer) criteria (Common Terminology Criteria for Adverse Events 5.0, EORTC QLQ-C30 : European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire -Cancer module 30) at 6 months

Pulmonary toxicity defined according to EORTC (European Organisation for Research and Treatment of Cancer) criteria (Common Terminology Criteria for Adverse Events 5.0, EORTC QLQ-LC13 : European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire - Lung Cancer module 13) at 6 months

Pulmonary toxicity defined according to EORTC (European Organisation for Research and Treatment of Cancer) criteria (Common Terminology Criteria for Adverse Events 5.0, EORTC QLQ-C30 : European Organisation for Research and Treatment of Cancer -Quality of Life Questionnaire - Cancer module 30) at 9 months

Pulmonary toxicity defined according to EORTC (European Organisation for Research and Treatment of Cancer) criteria (Common Terminology Criteria for Adverse Events 5.0, EORTC QLQ-LC13 : European Organisation for Research and Treatment of Cancer -Quality of Life Questionnaire - Lung Cancer module 13) at 9 months

Pulmonary toxicity defined according to EORTC (European Organisation for Research and Treatment of Cancer) criteria (Common Terminology Criteria for Adverse Events 5.0, EORTC QLQ-C30 : European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire - Cancer module 30) at 12 months

Pulmonary toxicity defined according to EORTC (European Organisation for Research and Treatment of Cancer) criteria (Common Terminology Criteria for Adverse Events 5.0, EORTC QLQ-LC13 : European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire - Lung Cancer module 13) at 12 months

Results of EuroQol (EQ-5D-5L) questionnaire

Results of Pulmonary Function testing (PFT) : FEV1

Results of Pulmonary Function testing (PFT) : FEV1/FVC

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Metastatic Colorectal Cancer: Treatment Response With Dynamic Contrast MRI	NCT00820456	Colorectal Neop... Hepatic Neoplas...	DCE-MRI	18 Years -	American College of Radiology
Dynamic Contrast Enhanced HCC SABR Liver Study	NCT02847767	Carcinoma, Hepa...	Perfusion Imagi...	18 Years -	British Columbia Cancer Agency
Dynamic Contrast Enhanced HCC SABR Liver Study	NCT02847767	Carcinoma, Hepa...	Perfusion Imagi...	18 Years -	British Columbia Cancer Agency
Lung Perfusion PET / CT Using Ga68-MAA for Preservation of Lung Function During Stereotactic Pulmonary Radiation Therapy	NCT04942275	SBRT Non-small Cell ... Lung Metastasis	Pre-therapeutic...	18 Years -	University Hospital, Brest
Lung Perfusion PET / CT Using Ga68-MAA for Preservation of Lung Function During Stereotactic Pulmonary Radiation Therapy	NCT04942275	SBRT Non-small Cell ... Lung Metastasis	Pre-therapeutic...	18 Years -	University Hospital, Brest
Lung Perfusion PET / CT Using Ga68-MAA for Preservation of Lung Function During Stereotactic Pulmonary Radiation Therapy	NCT04942275	SBRT Non-small Cell ... Lung Metastasis	Pre-therapeutic...	18 Years -	University Hospital, Brest
Dynamic Contrast Enhanced HCC SABR Liver Study	NCT02847767	Carcinoma, Hepa...	Perfusion Imagi...	18 Years -	British Columbia Cancer Agency

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