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Liver Extracts

Patients in this imaging substudy of the FOXFIRE clinical trial will undergo a perfusion CT prior to FOXFIRE protocol therapy( Ox/MDG chemo alone for 12 cycles in arm A or OX+MDG chemo for 12 cycles with Yttrium 90 SIRshpheres liver radioembolisaton in arm B cycle 2) on Day 1/2 cycle 2, Day 1/2 cycle 3 and Day 1/2 cycle 5 chemotherapy.

Perfusion CT scan

Ricky A Sharma, MBBChir

Ricky A Sharma, MB BChir

Esme J Hill, MBChB

The PERFORM study is a pilot study investigating the feasibility and usefulness of performing a novel CT (Computed Tomography)scanning technique called Perfusion CT(CTP) as an addition to normal CT scanning in patients recruited to the FOXFIRE trial. All patients recruited to FOXFIRE at the Oxford Radcliffe Hospitals and University Hospitals of Leicester will be invited to take part. FOXFIRE is a national randomised controlled trial in which patients with unresectable liver tumours secondary to colorectal cancer will receive treatment with standard chemotherapy alone, or with chemotherapy in combination with an internal radiotherapy treatment which delivers radioactive particles(SIR-spheres) to the liver via its own blood supply (radioembolisation). In the FOXFIRE study a normal CT scan would usually be performed prior to the start of treatment and also three months after the commencement of treatment to assess the cancer's response to treatment, particularly whether the tumour has changed in size as a result of treatment. Perfusion CT gives the normal information on changes in tumour size but also assesses whether the blood flow to the cancer has changed, which may allow earlier identification of treatment success compared to normal CT scans. All patients consenting to participate in the PERFORM study will undergo four perfusion CT scans: one before the treatment starts, and one at the start of each of the second, third and fifth cycles of chemotherapy. The aim is to determine the feasibility of measuring tumour perfusion for data analysis using perfusion CT and to establish if the tumour perfusion pattern at baseline or shortly after the start of therapy can predict response to radioembolisation or chemotherapy. This research is funded by the National Institute for Health Research Biomedical Research Centre in Oxford and Oxfordshire Health Services Research Committee.

PERfusion CT in the FOXFIRE Trial to Study Blood Flow to Liver Metastases

Perfusion Computed Tomography Pilot Study in the NCRN FOXFIRE Clinical Trial to Determine Blood Flow to Liver Metastases

Oxford University Hospitals NHS Trust

University Hospitals, Leicester

University of Oxford

Neoplastic Processes

Liver metastases randomized to receive sonoporation (US waves + gaseous microbubbles). The patient continue to receive the usual systemic chemotherapy

Liver metatstases not randomized to receive sonoporation (US waves + gaseous microbubbles). The patient continue to receive the usual systemic chemotherapy like the active comparator arm

Contrast enhanced ultrasound

Gaseous microbubbles (Sonovue) combinated with Ultrasounds

Sonoporation

The oscillations of ultrasound (US) contrast agent microbubbles under their activation by US waves engender a modulation of the permeability of biological barriers amplifying hence the extravasation of drugs and/or fluorescent markers through a process known as sonoporation. In such a way, the bioavailability of the therapeutic agent is augmented only in the area where US waves are focused. The objective now is to translate this therapeutic approach to the clinic by performing a feasibility study with the development of a therapy regime optimized for hepatic metastases of colorectal cancer.

In order to demonstrate the clinical feasibility of the therapeutic approach based on ultrasound and microbubbles, we will focus on patients with liver metastases of colorectal cancer treated with monoclonal antibodies in combination with chemotherapy.

Despite the increasing number of active molecules and the availability of news targeted therapies for cancer, therapeutic achievements remain modest for a number of tumor types. One of the major obstacles is inherent to the absence of specific delivery in the tumor tissue.

We have demonstrated recently that the oscillations of ultrasound (US) contrast agent microbubbles under their activation by US waves engender a modulation of the permeability of biological barriers amplifying hence the extravasation of drugs and/or fluorescent markers through a process known as sonoporation. In such a way, the bioavailability of the therapeutic agent is augmented only in the area where US waves are focused. The objective now is to translate this therapeutic approach to the clinic by performing a feasibility study with the development of a therapy regime optimized for hepatic metastases of colorectal cancer.

In order to demonstrate the clinical feasibility of the therapeutic approach based on ultrasound and microbubbles, we will focus on patients with liver metastases of colorectal cancer treated with monoclonal antibodies in combination with chemotherapy.

The work aims into evaluating the therapeutic efficacy of the proposed approach on a number of selected patients. We will follow the usual treatment schemes and we will apply imaging protocols to visualize tumor progression.

This technique of optimization of the intratumoral availability of anticancer drugs and based on sonoporation will improve the efficacy and safety of systemic chemotherapy by providing increased tumor uptake relative to normal tissue. This technique provides an ideal and easy strategy to optimize intratumoral drug delivery.

Targeted Delivery of Chemotherapy With Ultrasound and Microbublles

Targeted Delivery of Chemotherapy With Ultrasound and Microbubbles

Objective response for liver metastases with spiral CT scan and defined as decrease of at least 30% in the longer diameter of each selected liver metastases

Safety based on National Cancer Institute (NCI), Common Terminology Criteria for Adverse events (CTCAE)

Tolerance based on National Cancer Institute (NCI), Common Terminology Criteria for Adverse events (CTCAE)

Maximum percent reduction in tumor density (Hounsfield units) from baseline

Maximum percent reduction in tumor density from baseline

Assessment of tumor vascularity with Perfusion CT scan

Assessment of tumor vascularity with Dynamic Contrast-Enhanced US (DCE-US)

Measures of serum concentration of antibody anti-VEGF or anti-EGFR

Pharmacokinetic of antibody anti-VEGF or anti-EGFR

University Hospital, Tours

Urinary Tract, Sexual Organs, and Pregnancy Conditions

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Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

DCE-CT = Dynamic contrast enhanced CT - DCE-CT scans 4 weeks prior to and 8 weeks after starting treatment on study 2010-0085.

DCE-CT scans 4 weeks prior to and 8 weeks after starting treatment on study 2010-0085.

Chaan Ng, MD

This is a companion protocol to MD Anderson Cancer Center study 2010-0085 (Sequential Therapy in Advanced Renal Cell Carcinoma Therapy: The "START" Trial).

The goal of this clinical research study is to learn if dynamic contrast enhanced computed tomography (DCE-CT) scans can help researchers learn if the study drug received as part of study 2010-0085 (either everolimus, bevacizumab, or pazopanib) is working.

To perform a DCE-CT scan, a small amount of a special dye (called "CT contrast medium") is injected by vein into the body. Several CT images are then taken over a few minutes to learn how much dye spreads outside of the tumor. This can show how much blood flows to and from the tumor. By performing DCE-CT scans after several weeks on treatment, researchers may learn if changes in blood flow may be a sign that the treatment is working.

Study Procedures:

If you are found to be eligible to take part in this study, you will have a DCE-CT scan to check the status of the disease at the following times:

* Within about 4 weeks before you begin treatment on study 2010-0085.
* Eight (8) weeks after starting treatment on study 2010-0085.

Before each of the DCE-CT scans are performed, blood (about 1 tablespoon) will be drawn to check your kidney function.

If your doctor thinks it is needed, you will also have a standard-of-care CT scan at these timepoints to check the status of the disease.

Length of Study:

Your participation in this study will be over after the scan(s) 8 weeks after starting treatment on study 2010-0085. You will be taken off of this study if you leave the 2010-0085 study early.

This is an investigational study. The DCE-CT scan is commercially available. Using DCE-CT scans to check the status of kidney cancer is investigational.

Up to 120 patients will take part in this study. All will be enrolled at MD Anderson.

Dynamic Contrast Enhancement Computed Tomography for Evaluating Tumor Perfusion in Patients With Metastatic Renal Cell Carcinoma Receiving Targeted Therapies: Renal Cell Carcinoma (RCC) Scramble

Dynamic Contrast Enhancement Computed Tomography for Evaluating Tumor Perfusion in Patients With Metastatic Renal Cell Carcinoma Receiving Targeted Therapies: Companion to Protocol 2010-0085

Changes in perfusion parameters assessed at first re-staging (approximately 8 weeks) and shortly after initiating therapy (2 - 7 days), for three different therapies using organ-directed DCE-CT tumor assessments. Tumor BF of index lesions computed using commercially available software (GE CT perfusion) using the same index lesion assessed on follow-up scans.

PFS is calculated from the start of the study until disease progression.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
PERfusion CT in the FOXFIRE Trial to Study Blood Flow to Liver Metastases	NCT01410760	Metastatic Colo...	Perfusion CT sc...	18 Years -	University of Oxford
Targeted Delivery of Chemotherapy With Ultrasound and Microbublles	NCT03458975	Colorectal Canc... Hepatic Metasta...	MRI Perfusion CT sc... Contrast enhanc... Sonoporation	18 Years -	University Hospital, Tours
Dynamic Contrast Enhancement Computed Tomography for Evaluating Tumor Perfusion in Patients With Metastatic Renal Cell Carcinoma Receiving Targeted Therapies: Renal Cell Carcinoma (RCC) Scramble	NCT01224288	Renal Cell Carc...	Perfusion CT sc...	18 Years -	M.D. Anderson Cancer Center

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