Diseases and Abnormalities at or Before Birth

All Conditions

Symptoms and General Pathology

Neoplasms

Rare Diseases

Congenital Abnormalities

Recurrence

Glioblastoma

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

All Drugs and Chemicals

Anti-Infective Agents

Cardiotonic Agents

Amino Acids

Fluorides

Fluorodeoxyglucose F18

Deoxyglucose

Dihydroxyphenylalanine

Radiopharmaceuticals

Antimetabolites

Antiviral Agents

Dopamine

Dopamine Agents

Neurotransmitter Agents

Phenylalanine

Study subjects will receive 18FDG via an IV before undergoing one PET/CT scan over 60 minutes. They will then receive an IV injection of Gadovist for contrast before undergoing a multiparametric MRI scan. Subjects will also receive (18)F-FDOPA via an IV before undergoing another PET/CT scan over 60 minutes.

Positron Emission Tomography

Computed Tomography

Multiparametric Magnetic Resonance Imaging Scan

IV (intravenous) administration of radiotracer

Fludeoxyglucose F-18

fluorine F 18 fluorodopa

Bijoy Kundu, PhD

Florence Yan

The purpose of this pilot study will be to conduct a clinical trial using a time-of-flight PET scanner and MRI scanner to test an improved method for differentiating tumor recurrence from radiation necrosis in glioblastoma patients. We will attempt to do so by performing a static and dynamic FDG-PET scan, a static and dynamic FDOPA-PET scan, and a multiparametric MRI scan - then comparing the results with surgical pathology and static FDG-PET scans. We hypothesize that the new quantitative kinetic analytical methods using FDOPA in combination with FDG will provide crucial functional information to distinguish recurrent tumors from treatment-induced radiation changes in patients with treated brain neoplasms. This is important for improving patient outcomes by allowing treating physicians to more accurately tailor treatments. Furthermore, dynamic FDG and FDOPA PET will be combined with high resolution anatomic and physiologic MRI in order to develop a multimodal multiparametric approach for differentiating tumor recurrence from treatment effect.

PRIMARY OBJECTIVES:

I. The primary objective will be to evaluate the diagnostic accuracy of Dynamic PET imaging in differentiating tumor recurrence from treatment effect (radiation necrosis or pseudoprogression) in patients previously treated with chemo-radiation therapy for primary high grade gliomas. This will be accomplished by examining the concordance between the Dynamic PET imaging prediction and the criterion standard, which will be based on either surgical pathology or an integrated clinical/MRI determination within a 3-6 month interval after Dynamic PET imaging.

SECONDARY OBJECTIVES:

I. The diagnostic accuracy of Static PET imaging, advanced MRI, and advanced MRI + Dynamic PET imaging in differentiating tumor recurrence from radiation-induced necrosis in high grade glioma patients will be examined in the same exact way as just outlined for Dynamic PET imaging.

OUTLINE:

Subjects receive 18FDG (first scan) and (18)F-FDOPA (2-14 days from the first scan) intravenously (IV) slowly over a period of 15-20 seconds and then undergo dynamic PET scans over a period of 60-90 minutes. CT scans on the subjects are performed before the dynamic PET scans for 5 minutes. Subjects also undergo MRI brain examinations just prior to the FDOPA scan over a period of 1 hour, which includes T1 weighed, T1 weighted contrast enhanced, T2 weighted, Diffusion tensor imaging, MR spectroscopy, and Dynamic susceptibility contrast perfusion weighted (DSC-PWI) imaging.

All 5 study subjects will undergo the same procedures.

FDG and FDOPA PET Demonstration of Functional Brain Abnormalities

Will be derived from PET/CT scan imaging.

Will be derived from MRI brain scan imaging.

Including anatomic assessment based on T1, T2, and contrast enhanced T1 weighted imaging, MR spectroscopy data (choline, creatinine, and N-acetyl acetate peak integrals and ratios), MR perfusion data (relative cerebral blood volume), and diffusion tensor imaging data (apparent diffusion coefficient, fractional anisotropy)

To be compared with the imaging analyses for comparing ability to differentiate tumor recurrence from radiation necrosis.

University of Virginia

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Diagnostic Test: Brain MRI scan Female subjects at high risk for breast cancer that previously underwent more than 6 Gd-based contrast enhanced MRI exams of the breast.

Diagnostic Test: Brain MRI scan Age-matched female control subjects that never received Gd-based contrast agents.

Diagnostic brain MRI scan with the purpose to detect signal changes due to brain deposits of Gd.

Brain MRI scan

Barbara I Bennani-Baiti

Pascal A Baltzer

Purpose: To determine whether patients at high risk to develop breast cancer having received at least 6 cumulative dosages of macrocyclic Gd-based contrast media in the context of breast cancer screening by means of contrast-enhanced MRI.

Methods: Diagnostic study encompassing two arms: first, 50 patients having received ≥6 dosages of macrocyclic Gd-based contrast media in the course of MRI-based breast cancer screening will undergo brain MRI assessment for signal alterations due to Gd-deposits. The second arm consists of 50 healthy volunteers that never received Gd-based contrast agents, and undergoes the same brain MRI assessment as the patient-based arm 1 of the study. Signal intensities will be compared to assess the potential presence or absence of macrocyclic Gd-based contrast agent deposits in the brain.

In case of presence of signal alterations in arm 1 these will be further stratified by number of previously administered macrocyclic Gd-contrast agent doses.

Projected outcome: High cumulative dosages of macrocyclic Gd-based contrast agent either result or do not result in brain MRI signal alterations in healthy women participating in a high-risk screening program for the early detection of breast cancer that necessitates Gd-contrast agent enhanced breast MRI at regular intervals.

Female subjects exposed to Gd-based contrast media and female subjects not exposed to Gd-based contrast media will be examined by a diagnostic test (brain MRI scan) to determine the presence or absence of Gd-deposit related signal alterations in the brain.

The examined study population are exclusively female subjects.

Evaluation of Gadolinium Deposits in Healthy Women Participating in a High Risk Screening Program for Early Breast Cancer Detection

Due to a lack of funding IPD cannot be made publicly available.

Evaluation of Gadolinium Deposits in Healthy Women Participating in a High Risk Screening Program for Early Breast Cancer Detection in comparison to healthy volunteers without previous Gd-based contrast media exposure - signal intensities of various brain regions measured by different MRI sequences will be evaluated

Medical University of Vienna

Principal Investigator

Nervous System Diseases

Neoplasm Metastasis

Brain Neoplasms

Neoplastic Processes

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

One-time brain magnetic resonance (or computed tomography when magnetic resonance is contraindicated), plus circulating tumor DNA analysis, plus Testing Morbidity Index (TMI)

Brain Magnetic resonance (or computed tomography if magnetic resonance is contraindicated)

Brain imaging

One single blood draw for analysis of circulating tumor DNA

Analysis of circulating tumor DNA

Questionnaire regarding the participant's perception of brain imaging.

Testing Morbidities Index

Katarzyna Jerzak, MD, M.Sc

Katarzyna Jerzak, MD M.Sc

The goal of this multi-centre, prospective study is to assess the frequency of asymptomatic brain metastasis in patients with stage II or III Triple Negative or HER2 positive breast cancer. The main questions it aims to answer are:

1. What proportion of patients with stage II or III Triple Negative or HER2 positive breast cancer have asymptomatic brain metastases identified on a screening contrast-enhanced magnetic resonance imaging (or computed tomography when Magnetic resonance is not possible) of the brain?
2. How do patients feel about undergoing brain imaging to screen for asymptomatic Brain metastasis?
3. What clinical and tissue-based biomarkers are associated with asymptomatic detection of Brain metastasis?

Participants will undergo a brain imaging, collect one blood sample to perform ctDNA analysis, and fill the Testing Morbidities Index (TMI) after imaging is done. Procedures must take place within one year of initial diagnosis, either prior to or after completion of (neo)-adjuvant systemic therapy.

MRI Screening for Brain Metastases Among Patients With Triple Negative or HER2+ Stage II or III Breast Cancer

MRI Screening for Brain Metastases Among Patients With Triple Negative or HER2+ Stage II or III Breast Cancer: A Multi-centre Prospective Cohort Study

Correlation between initial clinical and pathological staging with the rate of asymptomatic brain metastasis as seen in the brain MRI Correlation of positive liquid biopsy (e.g. circulating tumor DNA) with the rate of asymptomatic brain metastasis as seen in the brain MRI

Correlation between initial clinical and pathological staging with the rate of future development of brain metastasis at the 1-year, 2-year and 3-year time points as captured by chart review.

Correlation of positive liquid biopsy (e.g. circulating tumor DNA) with the rate of future development of brain metastasis at the 1-year, 2-year and 3-year time points as captured by chart review.

Proportion of eligible patients with Stage II or III HER2+ breast cancer who have asymptomatic brain metastasis

Proportion of eligible patients with Stage II or III Triple Negative breast cancer who have asymptomatic brain metastasis

Proportion of patients who are approached about the study who agree to enroll

Patients' acceptability of the brain magnetic resonance imaging as evaluated by the "Testing Morbidities Index" (TMI)

Annual chart review to determine the frequency of patients who have subsequent brain imaging performed after the first trial magnetic resonance imaging

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
FDG and FDOPA PET Demonstration of Functional Brain Abnormalities	NCT04315584	Glioblastoma	Positron Emissi... Computed Tomogr... Multiparametric... Fludeoxyglucose... fluorine F 18 f...	18 Years -	University of Virginia
Evaluation of Gadolinium Deposits in Healthy Women Participating in a High Risk Screening Program for Early Breast Cancer Detection	NCT03393442	Gd-based Contra...	Brain MRI scan	18 Years - 80 Years	Medical University of Vienna
MRI Screening for Brain Metastases Among Patients With Triple Negative or HER2+ Stage II or III Breast Cancer	NCT06247449	Breast Cancer	Brain imaging Analysis of cir... Testing Morbidi...	18 Years -	Sunnybrook Health Sciences Centre
MRI Screening for Brain Metastases Among Patients With Triple Negative or HER2+ Stage II or III Breast Cancer	NCT06247449	Breast Cancer	Brain imaging Analysis of cir... Testing Morbidi...	18 Years -	Sunnybrook Health Sciences Centre

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