Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Addition of up to 10 minutes in MRI machine purpose of acquiring additional DTI images

The Philips Ingenia 3.0T is an MRI machine intended to be used by specialist radiologists in the hospital. It is able to acquire high quality images of wide variety of organs. For imaging the prostate, T2-weighted turbo spin-echo images are normally obtained in three orthogonal planes (axial, sagittal and coronal). This device is been clinically used in the MRI department in Belinson hospital.

MRI machine

The purpose of this study is to examine if investigators can improve diagnosis of prostate cancer by using MRI/DTI?

This is a prospective cohort study of the ability of MRI/DTI to diagnose prostate cancer in men undergoing prostate MRI.

Study design: Male adults who are scheduled to undergo MRI of the prostate, for clinical reasons, will be subjected to additional 10 minutes of image acquisition inside the MRI machine. The added MRI/DTI acquisition does not involve injection of additional contrast material. Investigators will compare between ability of the full mp-MRI images to diagnose prostate cancer to that of the MRI/DTI images

Prospective Cohort Study of the Ability of MRI/DTI to Diagnose Prostate Cancer

Prospective Cohort Study of the Ability of MRI/DTI to Diagnose Prostate Cancer in Men Undergoing Prostate MRI

Weizmann Institute of Science

Rabin Medical Center

Staff Uro-Oncologist

Rare Diseases

Glioma

Glioblastoma

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

Dermatologic Agents

All Drugs and Chemicals

Aminolevulinic Acid

Surgery to resect the GB using Diffusion Tensor Imaging (DTI) and intraoperative Ultrasound (iUS) (navigated iUS where available) in addition to standard care (i.e. neuronavigation based on preoperative MRI and intraoperative use of 5-aminolevulinic acid (5-ALA))

The comparator is standard care as per current NICE guidelines (i.e. neuronavigation based on preoperative MRI and intraoperative use of 5-ALA).

Standard of Care

Additional DTI scan during routine pre-operative tumour MRI scan, additional use of intraoperative ultrasound in addition to normal to standard of care (Neuronavigation and intraoperative 5-ALA)

Additional pre- and intra-operative imaging

Amy Taylor

Colin Watts

Giles Critchley

Neil Barua

Stephen Price

George Eralil

Sandeep Solanki

Anna Solth

Paul Brennan

Chittoor Rajaraman

Robert Corns

Michael Jenkinson

Edward McKintosh

Keyoumars Ashkan

Sophie Camp

Dipankar Nandi

Anil Varma

Damian Holliman

Stuart Smith

Puneet Plaha

James Palmer

Isaac Phang

Nik Haliasos

Yahia Al-Tamimi

Paul Grundy

Erminia Albanese

Functional and ultrasound-guided resection of glioblastoma: assessing the use of additional imaging during surgery to improve outcomes for patients with glioblastoma brain tumours

Stage 1 (IDEAL IIB study) of the trial is observational only and all participants will receive all technologies during surgery.

Stage 2 will be randomised. Randomisation will be via the web-based service provided by the Oxford Clinical Trials Research Unit (OCTRU), using the method of minimisation. Participants will be randomised 1:1 to either:

1. Standard care surgery (neuronavigation based on preoperative imaging and intraoperative use of 5-ALA)(Control arm)
2. Standard care surgery (neuronavigation based on preoperative imaging and intraoperative use of 5-ALA) AND of DTI neuronavigation and NiUS (Intervention arm)

At baseline all participants will undergo a routine preoperative neuronavigation MRI scan. Those participants randomised to the experimental arm, will also have a DTI scan (additional 5 minutes in the MRI). All participants will then undergo the planned resection of their tumour, with the additional technologies if they are in the experimental arm. Following surgery, participants in both arms have the same follow up schedule and undergo standard clinical care for a total of 24 months.

FUTURE-GB is a 2-Stage trial: Stage 1 is a non-randomised multicentre learning and evaluation Stage (IDEAL IIB study), and Stage 2 a prospective, multicentre definitive randomised controlled trial.

Functional and Ultrasound Guided Resection of Glioblastoma

FUTURE-GB Trial (Functional and Ultrasound-guided Resection of Glioblastoma) A 2-Stage Trial. A Learning Phase Evaluation of Participating Centres, Followed by a Randomised, Controlled Multicentre Phase III Trial.

To assess the sensitivity and specificity of the anatomico-spatial location of DTI fibre tracts compared with intraoperative direct electrical stimulation/behavioural change without stimulation but related to adjacent white fibre tract in patients undergoing awake surgery, or motor evoked potential changes in patients undergoing surgery.

Measured by sensitivity and specificity calculation using pre and post-surgery MRI images

To assess the sensitivity and specificity of iUS\* to identify the tumour boundary when compared with 5-ALA, navigated biopsies will be taken from tumour boundary tissue planned for resection.

Intra operative iUS\* images and post-operative MRI scans and Intraoperative biopsy samples

Sites are qualitatively assessed through a standardisation stage, providing feedback to enable learning and ensure the workflow is followed. Sites with satisfactory data will "progress" and pass into Stage 2.

The measures assessed in combination are:

1. Operation length, in normal range for this surgery.
2. Use of DTI neuronavigation \& iUS to achieve maximal safe tumour resection without major neurological deficit, measured by getting clear, relevant images for the DTI \& US scans, and accurate pre-operative tractography.
3. Extent of tumour resection (cm³ remaining) on postoperative MRI scan.
4. Surgical Complications/Serious Adverse Events-measured from recorded post-operative complications and a 6-month notes check to ensure patient safety.

If the assessment panel is satisfied with the data after \~3 recruits, a site will progress into Stage 2 of the trial, the RCT. Data will be analysed for Stage 1 once all sites have progressed through into Stage 2 of the trial.

This is measured by a composite of:

1. Change in global health status domain of the QLQ-C30 questionnaire (Quality of Life Questionnaire Cancer) from baseline to final questionnaire completion. Questionnaires are administered at baseline, 6 weeks, then every 3 months until 24months.
2. Progression Free Survival (PFS). This is measured by radiological tumour progression on imaging, which is taken 3-months post-op and 3-monthly thereafter.
3. Overall Survival (OS) with an event defined as either deterioration, progression or death.

This is measured using a combination of specific questions (physical functioning and social functioning) in the QLQ-C30 (Quality of Life Questionnaire Cancer) and BN20 questionnaire (Quality of Life Questionnaire Brain) (motor dysfunction and communication deficit questions), combined with the values of Progression Free Survival (PFS) and overall survival (OS) taken from the primary outcome.

Questionnaires are administered at baseline, 6 weeks, then every 3 months until 24months.

Defined similar to DFS with the exception that progression is excluded as an event (i.e. only deterioration or death are considered). There will be five time to deterioration outcomes, one for each of the domains utilised in the primary and secondary DFS outcomes, used in turn to define deterioration

OS (time from randomisation to death or trial closure)

PFS (time from randomisation to radiological tumour progression on imaging, as agreed in local MDT

This involves using the post-operative MRI scan as a reference point and making comparisons will the ensuing MRI reports that are recieved 3 months post-surgery and 3 monthly thereafter until 24 months post-surgery.

Extent of resection as percent of pre-operative tumour volume on postoperative contrast enhanced MRI

Number and type of surgical complications

Number of patients eligible for adjuvant treatment

Measured by any change in the functional performance assessment which consistes of a combination of:

1. The WHO (World Health Organisation) performance status
2. A 5-minute telephone mini-MoCA (The Montreal Cognitive Assessment, Montreal Version)
3. Barthel Index
4. MRC (Medical Research Council) grading of power in all 4 limbs

Assessments are made at baseline, at hospital discharge, 6 weeks post-op, 3 months post-op, then 3 monthly thereafter until 24 months.

Assessed using comparisons between the patient and proxy responses to the Quality of Life questionnaires administered. Specifically comparisons between the answers to questions 29 and 30 of the QLQ-C30.

Imperial College Healthcare NHS Trust

Efficacy and Mechanism Evaluation (EME) Programme

University of Oxford

Skin and Connective Tissue Diseases

Breast Neoplasms

The patients enrolled for the study will be women scheduled for breast MRI due to high risk screening or pretreatment evaluation. The patients will fill in a form regarding: age, hormonal status, risk factors, prior breast surgery or treatment (a form which is routinely filled out in our institution). They will then undergo a breast MRI scan, using the routine protocol in our institution. This will be directly followed by a DTI sequence, which takes about 10 minutes in addition to the regular examination. The DTI sequence is routinely used in other imaging institutions, as part of the breast MRI protocol.

Breast MRI

Ahuva Grubstein, MD

Introduction The most common breast cancer originates within the breast milk ducts, and is called ductal carcinoma. After the stage where the cancer is found only within the ducts, it invades the breast tissue beyond the ducts, and becomes invasive cancer (Infiltrating Duct Carcinoma). Breast cancer located within the ducts is called intra ductal carcinoma in situ- DCIS. DCIS is the developing cancer and usually does not metastasize. Another type of breast cancer originates within the breast lobules and is call lobular carcinoma.

Recently at the Weizmann Institute, Prof. Hadassa Degani and her group developed and imaging technique using breast MRI. This technique allows to map the three-dimensional structure of the milk ducts in the breast. The method is based on measuring the random movement (Brownian motion) of water molecules (diffusion) in different directions in the breast tissue, collecting diffusion images by using magnetic field gradients in different directions, allowing imaging of Diffusion tensor Imaging -DTI. Movement of water molecules within a unified solution is usually random and uniform in all directions, but the internal structures in biological systems (such as cells, pipelines, fiber) restrict the movement of water in certain directions. The DTI method exploits this feature by measuring the diffusion in various directions, thus enabling calculating images of biological structures \[1\]. This method was proved to be effective in mapping the brain's white matter fibers and is used routinely in clinical tests used to monitor neurological injuries \[2-4\]. This method was used for milk ducts mapping within breast tissue at the Weizmann Institute. The system that was developed at the Weizmann Institute, showed that the movement of water molecules along the milk ducts is faster than their movement across the ducts and therefore it was possible using this method to map the breast ductal system. Also this method showed that it is possible to detect and diagnose malignant changes within breast and to distinguish them from normal tissue and benign tumors using DTI. Changes in cell density and arrangement causes changes in the directional diffusion coefficients and the differences between them \[5-9\] Research Plan Summary A prospective preliminary study to evaluate the correlation between the DTI analysis of breast MRI and the results of conventional contrast enhanced breast MRI.

The patients enrolled for the study will be women scheduled for breast MRI due to high risk screening or pretreatment evaluation. The patients will fill in a form regarding: age, hormonal status, risk factors, prior breast surgery or treatment (a form which is routinely filled out in our institution). They will then undergo a breast MRI scan, using the routine protocol in our institution. This will be directly followed by a DTI sequence, which takes about 10 minutes in addition to the regular examination. The DTI sequence is routinely used in other imaging institutions, as part of the breast MRI protocol.

The exams will be read on our regular work stations, and in addition will be analyzed by software developed at the Weizmann Institute. Both interpretations will then be compared to each other and to clinical and pathological data

DTi Diffusion Findings in Breast MRI Screening and Diagnostic

colored scaling of DTI ranging from green to yellow and red as compare dynamic scan

head of mammography

Ganglion Cysts

Synovial Cyst

Germ Cells Tumors

All the patients received chemotherapy and radiotherapy.

radiotherapy

Xiaoguang Qiu, M.D.

Shuai Liu, M.D.

BOLD-fMRI and DTI scans are performed to patients with germ cell tumors in the basal ganglia before and after treatments. The changes of the MRI and muscle strength of patients during treatments are evaluated, and the association between these two are investigated.

Primary intracranial germ cell tumors are a specific entity of brain tumors with a variety of histological types and different degrees of malignancy. Intracranial GCTs make up 11.2% - 15.3% of primary intracranial tumors in Asian children compared with 3.6% in the US. And tumors located at the basal ganglia is much rarer.

The investigators realize that most of patients with tumors at this location are involved with motor disfunction. And after treatments, some patients get relieved dramatically, but some others failed to get similar outcomes. To better understand the mechanism causing this difference of treatment outcomes, the investigators perform BOLD-fMRI and DTI scans to patients with germ cell tumors in the basal ganglia before and after treatments. The changes of the fMRI and muscle strength of patients during treatments are evaluated, and the association between these two are investigated.

Evaluating Structural and Functional Changes of Brain by fMRI and DTI in Patients With Intracranial Germ Cell Tumors

Evaluating Changes of Brain Networks and White Matter Fibers by fMRI and DTI After Treatments in Patients With Germ Cell Tumors in the Basal Ganglia

The brain networks during treatments are compared by functional connectivity.

The white matter fibers damaged by tumor are evaluated by FA and MD value.

The limb muscle strength of patients are evaluated with the Medical Research Council (MRC) scale for muscle strength (grade 0-5).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Prospective Cohort Study of the Ability of MRI/DTI to Diagnose Prostate Cancer	NCT02934776	Magnetic Resona...	MRI machine	18 Years - 90 Years	Rabin Medical Center
Functional and Ultrasound Guided Resection of Glioblastoma	NCT05399524	Glioma Glioblas...	Standard of Car... Additional pre-...	18 Years - 70 Years	University of Oxford
Functional and Ultrasound Guided Resection of Glioblastoma	NCT05399524	Glioma Glioblas...	Standard of Car... Additional pre-...	18 Years - 70 Years	University of Oxford
DTi Diffusion Findings in Breast MRI Screening and Diagnostic	NCT03158441	Breast Cancer	Breast MRI	18 Years - 80 Years	Rabin Medical Center
Evaluating Structural and Functional Changes of Brain by fMRI and DTI in Patients With Intracranial Germ Cell Tumors	NCT03771625	Intracranial Ge...	radiotherapy	3 Years -	Beijing Neurosurgical Institute

Spots Global Cancer Trial Database for dti

Every month we try and update this database with for dti 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 dti

Every month we try and update this database with for dti 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 dti 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.