Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Nervous System Diseases

Rare Diseases

Lymphoma

Lymphoma, Non-Hodgkin

Central Nervous System Neoplasms

Nervous System Neoplasms

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Primary Central Nervous System Lymphoma

All Drugs and Chemicals

Fluorides

Fluorodeoxyglucose F18

Radiopharmaceuticals

Patients included in the study will be examined with both 18F-FDG and 18F-Fluciclovine as well as standard MRI in the PET/MRI scanner on two consecutive days, both in primary staging and for therapy assessment

PET scan with 18F-FDG as a tracer, taken both for primary staging and therapy assessment.

18F-FDG

PET scan with 18F-fluciclovine as a tracer, taken both for primary staging and response to therapy assessment.

18F-fluciclovine

clinical routine MRI examination, both for primary staging and response to therapy assessment.

standard MRI

Øystein Risa, phd

Primary central nervous system lymphoma (PCNSL) is a rare subtype of extranodal non-Hodgkins Lymphoma (NHL) with rising incidence and variable response to treatment. MRI is considered the most useful imaging modality of PCNSL, but conventional MRI has its limitations, and contrast-enhanced MRI sometimes does not clearly differentiate PCNSL from other neoplasm or non-neoplastic diseases.

Positron emission tomography (PET) could have a number of potential advantages in refining and improving the management of patients with PCNSL. Because of the rare incidence of PCNSL, the value of PET has however not been well defined in this subtype of lymphomas. There are a few studies that have investigated the role for FDG-PET and amino acid PET in the primary staging/diagnosis and response assessment in PCNSL patients, but the results are inconclusive. Further studies are therefore needed.

Previous studies support an integration of both MRI and PET for the routine diagnostic workup and response assessment for PCNSL, and the newly available simultaneous PET/MRI scanners may have the potential to improve imaging baseline accuracy, response assessment and add prognostic value in PCNSL.

The main aim of the study is to compare the sensitivity and specificity of a combined PET/MRI examination with the clinical routine MRI examination given to these patients today. It will be investigated whether PET (18F-FDG and 18F-fluciclovine) can provide additional prognostic value at baseline and in response assessment compared to MRI and established pre-treatment prognostic scores in PCNSL, and evaluate which PET/MRI parameters that are best suited as an imaging biomarker for progression-free survival.

Diagnostic Assessment of 18F-fluciclovine and 18F-FDG -PET/MRI of Primary Central Nervous System Lymphoma

Diagnostic Assessment of 18F-fluciclovine and 18F-FDG - PET/MRI of Primary Central Nervous System Lymphoma

of combined 18F-Fluciclovine-PET/MRI examination in comparison with the clinical routing MRI examination

of combined 18F-FDG-PET/MRI examination in comparison with the clinical routing MRI examination

which PET/MRI parameters that are best suited as an imaging biomarker for response evaluation and for progression-free survival at 12 months

St. Olavs Hospital

Norwegian University of Science and Technology

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

* Standard MRI will be performed
* Supine MRI will be performed
* Participant will receive mammography and ultrasound
* Breast Radiologist will take a brief survey.
* Patients will undergo upfront surgery or receive Neoadjuvant Therapy per standard of care
* Standard of care will be performed

Supine MRI

Neoadjuvant Therapy (NAT)

Ultrasound

Mammography

Standard of Care

Standard MRI

Tari King, MD

This research study involves the use of a common breast imaging modality (magnetic resonance imaging, 'MRI') and is investigating its role in evaluating surgical decision making for breast cancer when it is performed with the patient in a new position (lying on one's back) as opposed to in the standard position (lying on one's stomach).

The procedure involved is called a supine breast magnetic resonance imaging (MRI).In this study, the investigators are evaluating the value of supine MRI in surgical decision making for women with breast cancer either undergoing upfront surgery or for those anticipating surgery after receiving neoadjuvant therapy.

The purpose of this study is to assess the value of supine breast MRI as a new imaging method to assist in surgical treatment planning. It is possible that the use of supine breast MRI will help your doctor see the size and location of tumors more accurately

Supine MRI in Breast Cancer Patients Undergoing Upfront Surgery or Receiving Neoadjuvant Therapy

Comparing tumor size as measured on prone MRI images with tumor size as measured on final pathology among pts undergoing upfront surgery and among pts undergoing neoadjuvant chemotherapy. In the neoadjuvant chemotherapy group the post-treatment MRI images were used.

Compared tumor size as reported by radiologist on the clinical report between Supine Breast MRI and The Pathologic Residual Tumor Size as reported by the pathologist on the final surgical pathology report..

Correlate maximal tumor Dimensions as measured by the radiologist between the Prone and Supine MRI Images

Reported as the proportion of surgeons answering yes. Surgeon reported answers to surveys asking if the supine MRI helped in the performance of the surgical procedure.

Dana-Farber Cancer Institute

Principal Investigator

The definition does not differ from the clinicaltirals.gov definitions.

* Standard MRI will be performed
* Supine MRI will be performed
* Participant will receive mammography and ultrasound
* Breast Radiologist will take a brief survey.
* Patients will undergo upfront surgery or receive Neoadjuvant Therapy per standard of care
* Standard of care will be performed

Supine MRI

Neoadjuvant Therapy (NAT)

Ultrasound

Mammography

Standard of Care

Standard MRI

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Tari King

Comparison of tumor size between standard (prone) MRI imaging and surgical pathology

Standard (Prone) MRI Tumor Imaging

Analysis performed of 38 patients with Prone MRI imaging measurements and surgical pathology measurements

Correlation Between Prone Breast MRI for Estimation of Tumor Size and Final Pathology Tumor Size

Patients with both supine MRI measurements and pathologic tumor size measurements

Supine MRI and Pathologic Tumor Size

We analyzed MRI tumor size and pathologic tumor size for 26 pts with both supine MRI measurements and final pathology measurements

Correlation Between Supine Breast MRI for Estimation Of Tumor Size and The Pathologic Tumor Size

comparison of maximum tumor dimension as measured on prone MRI imaging versus supine MRI imaging

Patients With Imaging in Both the Prone and Supine Positions

40 pts who had both a prone and a supine MRI measurement of tumor size

Correlation of Breast Tumor Dimensions Between Prone and Supine Imaging Positions.

Patients having supine MRI imaging and proceeding with breast conserving surgery

Breast Conserving Surgery Patients

among 30 pts analyzed, 13 surgeons reported the supine imaging was helpful whereas 17 surgeons reported the imaging was not helpful

The Perceived Benefit Of Supine MRI For Surgical Planning As Measured By The Collective Results Of A Survey Of Surgeons Performing Breast-conserving Therapy (BCT) In Our Study Patient Population

Overall Study

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Patients will have a standard of care MRI, then consent to study participation and have an upright MRI.

Patients will consent to participate in the study, then do two MRIs in random order.

Indomitable Magnetic Resonance Imaging Scanner, magnetic resonance imaging using 0.6 T strength

Upright MRI

Monali Fatterpekar, Ph.D.

Cristina Pasat-Karasik

Ash Tewari, MD

This is an investigator initiated study to test the efficacy of an upright MRI (Magnetic Resonance Imaging) for the screening of prostate cancer. The purpose of this study is to compare Upright MRI as a technique to PSA (Prostate Specific Antigen) and current MRI imaging. It will take place at Mount Sinai Hospital, and last for a total of about 5 years. Eligible patients will be determined by the urologist. The target population is men who are at risk for prostate cancer, as determined by the urologist. Diagnostic criteria will include elevated PSA and an abnormal digital rectal exam (DRE). After patients are screened and determined eligible, they will be asked to have a seated MRI using the Indomitable Magnetic Resonance Imaging Scanner, Ex vivo magnetic resonance imaging using 0.6 T strength, as well as a standard of care closed 3T MRI. After each scan, the patient will be given a series of questionnaires to assess their comfort level during the scan. Patients will be followed every 6 months after completion of (or early withdrawal from) study enrollment until 5 years.

Prostate cancer (PCa) is the second most common cancer among men in the United States, with over 180,000 new cases diagnosed in 2016. This commonality implies that set standards need to be set and devise effective tools to screen and diagnose prostate cancer. Today, prostate specific antigen (PSA) test is the most widely adopted screening method for PCa. Since its introduction in 1979, it has helped in earlier diagnosis of PCa and has had a marked shift on the stage at which PCa is identified. PSA, although popular as a screening tool, has several shortcomings. It is organ-specific rather than cancer-specific, which means that its values can be elevated even for non-malignant conditions . Indeed, PSA based screening has reported positive predictive value as low as 30% (PSA cutoff \>4.0 ng/dL) for detecting prostate cancer and an over diagnosis rate of 50%, which leads to unnecessary biopsies and aggressive treatments of men with clinically indolent (insignificant) disease.

Current diagnostic pathway of prostate cancer requires men with elevated PSA and abnormal Digital Rectal exam to undergo a Trans Rectal Ultra Sound (TRUS) guided biopsy. TRUS is a blind-systematic biopsy, which randomly samples prostate tissue. This can lead to missing or under-diagnosing clinically significant cancer and over-diagnosing clinically insignificant disease. TRUS biopsy is itself associated with morbidity, mainly in the form of hematuria, hematospermia, pain, urinary retention and sometimes can cause life-threatening sepsis.

Many of the PSA screened detected prostate cancers detected on TRUS are clinically insignificant and even if left untreated have little to no clinical impact on an individual's remaining life. Overtreatment resulting from over diagnosis often leads to side effects like erectile dysfunction (approx. 60%) from radical therapy and urinary incontinence.

Prostate Biopsy Cores and/or Punch Cores from Radical Prostatectomy Specimen

Women do not have prostates and this is a study of prostate health

Upright MRI for Prostate Cancer Screening

Feasibility and Efficacy of Upright MP - MRI for Prostate Cancer Screening

To compare performance characteristics of Upright MP-MRI versus 3T MP-MRI in detecting clinically significant PCa and PCa in general.

Claustrophobic Questionnaire (CLQ) is a 46 item instrument, each item score on a likert scale from 1-5, full scale from 36 to 180, with higher score indicating more anxiety.

NCCN Distress Thermometer is a visual scale - full scale from 0-10, higher score indicating higher level of distress

Magnetic Resonance Imaging-Anxiety Questionnaire (MRI-AQ) is a 15 item instrument, each item score on a likert scale from 1 to 4, full scale range from 15 to 66, with higher score indicating higher degree of anxiety.

To compare the diagnostic yield of using MP-MRI with thresholds PSA density used for detecting prostate cancer.

Number of correctly identified side of prostate unaffected in men with pathological disease

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Diagnostic Assessment of 18F-fluciclovine and 18F-FDG -PET/MRI of Primary Central Nervous System Lymphoma	NCT03188354	Lymphoma, Non-H... Central Nervous...	18F-FDG 18F-fluciclovin... standard MRI	18 Years -	Norwegian University of Science and Technology
Supine MRI in Breast Cancer Patients Undergoing Upfront Surgery or Receiving Neoadjuvant Therapy	NCT02956473	Breast Cancer	Supine MRI Neoadjuvant The... Ultrasound Mammography Standard of Car... Standard MRI	18 Years -	Dana-Farber Cancer Institute
Supine MRI in Breast Cancer Patients Undergoing Upfront Surgery or Receiving Neoadjuvant Therapy	NCT02956473	Breast Cancer	Supine MRI Neoadjuvant The... Ultrasound Mammography Standard of Car... Standard MRI	18 Years -	Dana-Farber Cancer Institute
Diagnostic Assessment of 18F-fluciclovine and 18F-FDG -PET/MRI of Primary Central Nervous System Lymphoma	NCT03188354	Lymphoma, Non-H... Central Nervous...	18F-FDG 18F-fluciclovin... standard MRI	18 Years -	Norwegian University of Science and Technology
Upright MRI for Prostate Cancer Screening	NCT03474913	Prostate Cancer Elevated PSA Elevated Prosta...	Upright MRI Standard MRI	18 Years - 100 Years	Icahn School of Medicine at Mount Sinai

Spots Global Cancer Trial Database for standard mri

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