Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Breast Neoplasms

Body Weight

Breast Diseases

Skin Diseases

High Risk Breast Cancer Patients (all subjects)

An addition 90 seconds of DWI will be added to a clinical breast MRI for all patients agreeing to participate in the study.

Diffusion-weighted MR imaging

Cherie Kuzmiak, DO

Purpose: The purpose of this pilot study is to evaluate whether MRI of the breasts with diffusion-weighted MR imaging can identify features more specific for breast cancer in women at high-risk of developing breast cancer.

Participants: One hundred asymptomatic women at high-risk for breast cancer recommended for a clinical breast MRI identified through the UNC Breast Clinic will be consecutively recruited for this study.

Procedures (methods): Each patient will undergo a clinical breast MRI and the addition of a single 90 second diffusion weighted sequence. A reader study will be conducted at UNC after the completion of patient accrual. The images will be analysed for lesions, enhancement patterns, diffusion weighted imaging data and correlated with any pathology or 1 year follow-up MRI exam. The study information will be entered into a secure database and analyzed.

Enrollment and Recruitment:

A total of 100 high-risk women will be enrolled in this pilot study. High-risk for this study is defined as women at significantly increased risk of breast cancer. The Investigators will use the American Cancer Society Guidelines for Breast Screening with MRI as adjunct to mammography \[2\]. These guidelines recommend annual screening mammography for high risk women including BRCA mutations, first-degree relative of BRCA carrier, lifetime risk 20-25% or greater, previous history of chest radiation age 10 to 30 years and other syndromes related to increased breast cancer risk. We also included women with a history of previous high risk breast lesion(s) such as atypical hyperplasia, lobular carcinoma in situ or atypical lobular hyperplasia and a personal history of breast cancer by clinical consensus.

Patients who have been scheduled for the study will be contacted by research staff by phone to ask if they would be interested in participating in a research study. A script will be used to determine if patient is interested in hearing about a research study, if not the call will be discontinued immediately. If yes, more details will be provided to the patient to make a determination if they would like to participate.

If the patient is interested, she will be asked to come into the UNC MRI Department one hour prior to her scheduled MRI appointment. On the day of her MRI study, the patient will meet with the study coordinator or other assigned listed study personnel and will consent the subject to this study. Research coordinator/listed study personal will go through the consent form with the patient and answer any questions she may have. If patient agrees to participate after review of consent form, the patient will sign and date, the coordinator will then sign and date and patient will be formally enrolled. The patient will then undergo her ordered clinical breast MRI followed by one diffusion weighted MRI sequence.

Imaging Procedure: Each eligible patient, who provides consent for the study, will undergo a MR imaging screening questionnaire. If the patient has no contraindications, an intravenous line will be placed into a vein in the patient's arm and the patient will be placed prone with her breasts in a dedicated MRI breast coil. The patient will be given earplugs to decrease the noise level while in the magnet during the 45 minute total time period. High-resolution MRI sequences of the breasts and axillary regions will be performed before and after a gadolinium-DTPA bolus injection as per ordered clinical breast MRI protocol. Afterwards, one diffusion-weighted (DW) MRI sequence of the breast(s) will be performed. The DW sequence takes approximately 90 seconds.

The clinical images will be interpreted as per clinical protocol. The clinical radiologists will not have DW images to interpret. Therefore, it will not influence clinical decision concerning therapy.

Needle Core Biopsy/Surgery: All patients who are recommended for a needle core biopsy or open surgical biopsy for a breast lesion from their clinical Breast MRI will be scheduled by their surgeon. The radiologist performing the MRI-guided needle core biopsy or the surgeon performing the open surgical biopsy will be blinded to the results of the DW imaging, and therefore it will not influence clinical decision concerning therapy.

Reader Study: Five readers, radiologists that are experts in breast imaging and who are blinded to the study results, will be given de-identified MRI and DWI MRI images from the patient's entry MRI (MRIe) study and 1-year follow-up MRI (MRIf) study. Study radiologist data sheets will be completed for each study. The reader will have to complete the data sheets for MRIe before he/she can read and evaluate MRIf. The readers are blinded to the pathologic data at all times. For each condition MRIe and MRIf, each reader will check one of the checkboxes of each query that presents the lesion type (mass or non-mass enhancement), anatomic location (upper outer, upper inner, lower outer, lower inner or subareolar), largest dimension in centimeter, signal intensity on T1- and T2-weighted images (high, iso- or low to the fibroglandular tissue), morphology such as shape (round, oval, lobulated or irregular) and margin(smooth, irregular or spiculated) for mass, distribution (focal, linear, ductal, segmental or regional) for non-mass enhancement, enhancement pattern (homogeneous, heterogeneous, rim enhancement, dark internal septations, enhancing internal septations or central enhancement for mass; homogeneous, heterogeneous, stippled/punctate, clumped or reticular/dendritic for non-mass enhancement) and kinetic curve patterns on contrast-enhanced MRI (persistent, plateau or washout), signal intensity on DWI MRI /ADC map (high, iso-, low to the fibroglandular tissue) and an ADC value marked through quantitative analysis on the DWI study. The readers will assign any lesion(s) as benign, probably benign, suspicious and highly suggestive of malignancy according to the imaging findings and decide the probability of malignancy in percentages on contrast-enhanced MRI and DWI MRI, independently for the entry and final MRI study. After each radiologist reader has completed the data sheets for each patient, the data will be entered into a secure data base for statistical analysis.

Diffusion Weighted MR Imaging of the Breasts in Women at High Risk of Breast Cancer: A Pilot Study

Lesions will be identified by 5 trained radiologists in a reader study. The identification of lesions will be confirmed by pathologists, or if no biopsy is performed, then truth will be determined after a 1-year follow-up MRI/MRI DWI.

Trained radiologists will complete a series of questionnaires about identified lesions. Using these questionnaires, a mixed-effect ANOVA model (Obuchowski and Rockette, 1995) is to fit these summary measures of diagnostics accuracy. To test the primary hypothesis , an approximately t-distributed statistic based on Obuchowski and Rockette (1995) will be used and we reject the hypothesis if the statistic is larger than 95% percentile of a central student's t-distribution with one degree of freedom.

University of North Carolina, Chapel Hill

Behaviors and Mental Disorders

Rare Diseases

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Quality of Life

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Temozolomide

Only neurological and neuropsychological assessment as per normal clinical routine and conventional and advanced functional, resting-state MRI acquisitions

Patients submitted to motor rehabilitation program aimed at learning unimanual and bimanual coordinated sequences, along with personalized exercise according to tumor location (frontal vs parietal). For 6 months each patient will perform the motor training program in outpatient training session, checked by a physiotherapist for corrected execution at home 3 times/week, and is assessed for the correct training execution and progresses in training sessions each month, by physical therapists at the Rehabilitation Unit and on a weekly schedule by on-line distant monitoring (telemedicine).

Temozolomide-based regimen of 6 months duration is applied. Treatment will be discontinued in case of toxicity (G2-G4).

Temozolomide-based regimen of 6 months duration is applied. Treatment will be discontinued in case of toxicity (G2-G4).

Patients will also be submitted to motor rehabilitation program aimed at learning unimanual and bimanual coordinated sequences, along with personalized exercise according to tumor location (frontal vs parietal). For 6 months each patient will perform the motor training program in outpatient training session, checked by a physiotherapist for corrected execution at home 3 times/week, and is assessed for the correct training execution and progresses in training sessions each month, by physical therapists at the Rehabilitation Unit and on a weekly schedule by on-line distant monitoring (telemedicine).

rs-fMRI + neurological and neuropsychological evaluation at preoperative timepoint and 1-2 months postop, 3-4 months postop, 6-8 months postop, 12 months postop

Resting State Functional Magnetic Resonance Imaging (rs-fMRI)

personalized motor rehabilitation for 6 months + rs-fMRI + neurological and neuropsychological evaluation before starting motor rehabilitation, at 2-3 months during rehabilitation, 6-9 months during rehabilitation, before surgery (if surgery indicated by tumour board), 1 month postop, 2-3 months postop

Up-front Motor Rehabilitation

Temozolomide at either 6 cycles consisting of 150-200 mg per square meter for 5 days during each 28-day cycle, or metronomic schedule, + rs-fMRI + neurological and neuropsychological evaluation before starting motor rehabilitation, at 2-3 months during rehabilitation, 6-9 months during rehabilitation, before surgery (if surgery indicated by tumour board), 1 month postop, 2-3 months Post

Up-front Chemotherapy

Lorenzo Bello, MD

Background Lower-grade-gliomas affect young patients, thus the longest progression-free-survival (PFS) with a high level quality of life is crucial. Surgery most significantly impacts on tumor natural history, postponing recurrence, improving symptoms, decreasing the need of adjuvant therapies, with extent of resection, gross-total and supra-total (GTR and STR), strongly associating with longest PFS. Achievement of GTR or STR depends on the degree of functional reorganization induced by glioma. Consequently, a successful treatment fostering neural circuit reorganization before surgery, would increase the chance of GRT/STR.

Hypothesis The plastic potential of motor system suggests that reorganization of circuits controlling hand movements could be presurgically fostered in LGG patients by enhancing plasticity with up-front motor-rehabilitation and/or by decreasing tumor infiltration with up-front chemotherapy. Advanced neuroimaging allows to infer the neuroplasticity potential. Intraoperative assessment of the motor circuits functionality will validate reliability of preoperative analyses.

Aims The project has 4 aims, investigating: A) the presurgical functional (FC) and structural (SC) connectomics of the hand-motor network to picture the spontaneous reorganization and the influence of clinical, imaging and histomolecular variables; B) the dynamic of FC and SC after tumor resection; C) changes in FC and SC maps after personalized upfront motor rehabilitation and/or chemotherapy; D) the effect of FC and SC upfront treatment on the achievement of GTR/STR preserving hand dexterity.

Experimental Design Resting-state fMRI and diffusion-MRI will provide FC and SC maps pre- and post-surgery; personalized up-front motor rehabilitation and/or chemotherapy will be administered; Intraoperative brain mapping procedures will generate data to validate the maps.

Expected Results

1. Provide a tool to render the motor functional reorganization predictive of surgical outcome.
2. Identify demographic, clinical and imaging variables associated with functional reorganization.
3. Describe the gain induced by up-front treatment.
4. Distinguish "patterns" predicting chance for GTR/STR from "patterns" suggesting need for up-front treatment.

Impact On Cancer Results will increase the achievement of GTR/STR, preserving motor integrity, with dramatic impact on LGGs natural history.

Patients immediately candidate for resection will be assessed neurologically, neuropsychologically and by functional MRI. Extent of resection will be assessed on \<48hrs and 2-month MRI. Neurological and neuropsychological assessment will be performed during regular follow-up. Patients not requiring an adjuvant treatment according to tumor board meeting will be submitted to functional MRI at 4-8 and 12 months from surgery. Patients not immediately eligible for resection will be submitted to biopsy for histomolecular definition. Patients not requiring radiation therapy will be submitted to neurological, neuropsychological, and functional MRI evaluation. Upon clinical context, patients will undergo motor rehabilitation and/or chemotherapy. After 3-6 months, patients will undergo functional MRI and evaluated for surgery. Neurological and neuropsychological evaluation will be performed at treatment initiation, every month during treatment, at admission for surgery and 1 month after surgery.

Personalized Rendering of Motor System Functional Plasticity Potential to Improve Glioma Resection and Quality of Life

ARAT test (Grasp, Grip, Pinch, each consisting of 3 items scoring 0 \[not performed, 1/2 abnormal, 3 ok\]), De Renzi test (24 complex gestures with individual scoring 0-3 \[0 no execution/always abnormal, 2/1 ok after 1 or 2 trials, 3 ok\] each evaluating one or more among finger movements \[total score 0-36\], hand movements \[total score 0-36\], hand and finger position \[total score 0-36\], sequence of movements \[total score 0-36\], meaningful gestures \[total score 0-36\], meaningless gestures \[total score 0-36\]; tool pantomime for 10 objects individual score 0 if always incorrect, 1 if correct after command repetition, 2 correct immediately, total score range 0-20)

Language: Naming test; Fhonemic and Semantic Fluency Verbal and Spatial Memory: 15 Rey's Words; Recall Rey figure; Visuo-spatial test: Rey's Copy; Cancellation Test Attention and Executive Functions: Attentive matrice and Trail Making test For each listed test, equivalent score, from 0 to 4, is used.

Mood Disorders. HADS test (score 0-21 : 0-7= Normal; 8-21 Mood disorders

University of Turin, Italy

University of Milan

Full Professor

Neoplasm Metastasis

Estrogens

Progesterone

According to the modified criteria of Bloom and Richardson grading system: grade 1, 2 and 3

Group A: axillary lymph node metastasis Group B: no axillary lymphatic metastasis

NPI = pathological tumour size (cm) × 0.2 + lymph node stage (1, 2 or 3) + histological grade (1, 2 or 3)

The cut-off points of the index were 3.4 and 5.4 to divide patients into the good (≤3.4), moderate (3.41-5.4) and poor (\>5.4) prognostic groups

AYNUR OZEN, MD

The purpose of this study is to determine findings of positron emission tomography and diffusion weighted magnetic resonance in primary lesion and axillary metastasis of breast cancer and compare of two imaging modality in these patients.

We aimed that to correlate both primary lesion 18F-fluorodeoxyglucose (FDG) maximum standardized uptake value (SUVmax) and diffusion-weighted imaging (DWI) apparent diffusion coefficient (ADC) with clinicopathological prognostic factors and compare the prognostic value of these indexes in breast cancer in this study. The evaluated and compared parameters are SUVmax and ADC according to age, tumour size, lymph node metastasis, receptor status, histologic grade, modified Nottingham prognostic index.

The Prognostic Value of FDG PET/CT and Diffusion-weighed Imaging on Breast Cancer

The Prognostic Value of FDG PET/CT and Diffusion-weighed Imaging on Detection of Primary Tumor and Axillary Metastasis for Breast Cancer: SUVMax Against to ADC

Bagcilar Training and Research Hospital

Aynur Ozen

Nervous System Diseases

Diseases and Abnormalities at or Before Birth

Neurofibromatoses

Neurofibromatosis 1

Neurofibroma

Nerve Sheath Neoplasms

Neurofibrosarcoma

Syndrome

Neoplastic Syndromes, Hereditary

Neurocutaneous Syndromes

Heredodegenerative Disorders, Nervous System

Neurodegenerative Diseases

Genetic Diseases, Inborn

Peripheral Nervous System Diseases

Neuromuscular Diseases

Nervous System Neoplasms

Peripheral Nervous System Neoplasms

Fibrosarcoma

Neoplasms, Fibrous Tissue

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Sarcoma

Neurofibromatosis

Neurofibromatosis Type 1

Malignant Peripheral Nerve Sheath Tumor

Soft Tissue Sarcoma

All patients diagnosed with neurofibromatosis type 1. GROUP 1:ADDITIONAL IMAGING OR SURGERY There will be patients with high-risk neurofibromas (potential malignant). These patients will underwent additional examinations or surgery (outside this study). Follow-up MRI within 2 years (study MRI )

GROUP 2:

No suspicious lesions at MRI. Follow-up within 2 years(Study MRI).

No specific intervention is necessary. If a suspicious lesion is diagnosed on MRI, further investigation will be planned (PET-CT or surgery - biopsy)

Additional imaging or surgery

Steven Pans, MD

Whole body MRI will be performed in patients with neurofibromatosis Type 1

PURPOSE 1:

To determine the total tumor load (neurofibroma) and to diagnose plexiform neurofibromas or malignant peripheral nerve sheath tumors. All patients will be scanned two years after the baseline whole body MRI to investigate to investigate the changes of total tumor load.

PURPOSE 2: added value of diffusion weighted imaging in diagnosis of high-risk neurofibromas

PURPOSE 3 : to determine the apparent diffusion coefficient of the malignant nerve sheath tumors and neurofibroma.

PURPOSE 4 : correlation between histopathology of the surgically resected neurofibroma/malignant nerve sheath tumors and MRI findings

Whole Body Magnetic Resonance Imaging With Diffusion Weighted Imaging : Potential Role in Neurofibromatosis

Estimation of the total tumor load of neurofibromas with whole body MRI (head to knee). Diagnosis of high risk neurofibroma in the chest, abdomen, pelvis, and extremities with T2-weighted sequence and diffusion weighted sequence.

Some patients with neurofibromatosis have lesions, pre-malignant or malignant neurofibromas. Additional imaging (PET-CT), a biopsy or surgical treatment is necessary in combination with histopathology of the lesion.

Universitaire Ziekenhuizen KU Leuven

Medical Doctor Radiologist

Blood and Lymph Conditions

Lymphedema

Lymphatic Diseases

Breast cancer related lymphedema cases receive observational magnetic resonance imaging before and after lymphovenous anastomosis.

Free water elimination diffusion MRI and diffusion kurtosis MRI techniques

Diffusion magnetic resonance imaging

Yeefan Lee, MD

Li-Wei Kuo, Ph.D.

In this project, the investigators aim to investigate the imaging approaches for breast cancer-related secondary lymphedema. The clinical study aims to optimize the conventional MRI methods for mapping lymphedema and assess the post-surgical therapeutic effects in longitudinal follow-up studies. Additionally, a normal imaging database of lymphedema MRI images will be established for future reference. For pre-clinical animal study, investigators aim to develop and integrate two novel MRI methods, including free water elimination diffusion MRI and diffusion kurtosis MRI techniques. By integrating clinical and pre-clinical studies, the investigators aim to establish a precise imaging tool for evaluating the therapeutic effects of lymphedema for following translational applications.

A total of three sub-projects will be conducted in this project. Sub-project 1 will establish a pre-clinical rat model for lymphedema and develop novel MRI methods, including diffusion kurtosis MRI and free water elimination diffusion MRI techniques, for mapping tissue characteristics of lymphedema. Sub-project 1 will be complemented with the clinical images provided by sub-project 2, yielding more information about the lymphedema. Sub-project 2 aims to optimize the clinical MRI methods for mapping lymphedema and quantitatively assess the severity of lymphedema. A normal imaging database will be established for reference. Sub-project 2 and sub-project 3 will be complementary in co-developing the image assessment of post-surgical therapeutic effect. Sub-project 3 will quantitatively evaluate the severity of lymphedema secondary to different kinds of axillary treatments by using the clinical MRI methods for establishing longitudinal monitoring and prediction approaches. It also focuses on the pre-surgical and post-surgical evaluation of lymphedema undergone supermicrosurgical technique by using the clinical MRI methods.

Novel MRI Techniques on Evaluation of Lymphedema

Development and Optimization of Novel MRI Techniques on Evaluation of Therapeutic Effects for Lymphedema Secondary to Breast Cancer Treatment: An Integrated Study of Pre-clinical Animal Models and Clinical Follow-up

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Diffusion Weighted MR Imaging of the Breasts in Women at High Risk of Breast Cancer: A Pilot Study	NCT01938157	Breast Cancer	Diffusion-weigh...	21 Years -	University of North Carolina, Chapel Hill
Personalized Rendering of Motor System Functional Plasticity Potential to Improve Glioma Resection and Quality of Life	NCT06381726	Glioma Glioma, Maligna...	Resting State F... Up-front Motor ... Up-front Chemot...	18 Years -	University of Milan
The Prognostic Value of FDG PET/CT and Diffusion-weighed Imaging on Breast Cancer	NCT01942759	Breast Neoplasm...		-	Bagcilar Training and Research Hospital
Whole Body Magnetic Resonance Imaging With Diffusion Weighted Imaging : Potential Role in Neurofibromatosis	NCT01777451	Whole Body Imag... Magnetic Resona... Neurofibromatos... Diffusion Magne... Peripheral Nerv...	Additional imag...	6 Years - 50 Years	Universitaire Ziekenhuizen KU Leuven
Novel MRI Techniques on Evaluation of Lymphedema	NCT05804643	Lymphedema of U...	Diffusion magne...	20 Years -	National Taiwan University Hospital
Novel MRI Techniques on Evaluation of Lymphedema	NCT05804643	Lymphedema of U...	Diffusion magne...	20 Years -	National Taiwan University Hospital
Whole Body Magnetic Resonance Imaging With Diffusion Weighted Imaging : Potential Role in Neurofibromatosis	NCT01777451	Whole Body Imag... Magnetic Resona... Neurofibromatos... Diffusion Magne... Peripheral Nerv...	Additional imag...	6 Years - 50 Years	Universitaire Ziekenhuizen KU Leuven

Spots Global Cancer Trial Database for diffusion magnetic resonance imaging