Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Heart and Blood Diseases

Breast Neoplasms

Mitral Valve Insufficiency

Breast Diseases

Skin Diseases

Nadeem Pervez, MBBS, FFRRCSI, FRCPC

Correlation between MRS and Tumor Response Therapy in Breast Cancer.

Correlation between MRS (Magnetic Resonance Spectroscopy and Tumor Response to Radiation in Breast Cancer

Correlation Between MRS (Magnetic Resonance Spectroscopy) and Tumor Response to Radiation Therapy in Breast Cancer

measuring choline, water and fat levels by proton magnetic resonance spectroscopy in breast tumors in response to treatment

AHS Cancer Control Alberta

Patients with newly diagnosed stage II A-B or III A-C breast cancers who are scheduled to start systemic chemotherapy.

3 Scans performed before chemotherapy, 21 days (plus or minus 3 days) after start chemotherapy (Day 1 = your first day of chemotherapy), and at end of chemotherapy/before surgery.

Magnetic Resonance Imaging (MRI)

3 MRI Scans with MRS performed before chemotherapy, 21 days (plus or minus 3 days) after start chemotherapy (Day 1 = your first day of chemotherapy), and at end of chemotherapy/before surgery.

Magnetic Resonance Spectroscopy (MRS)

Gary Whitman, MD

The goal of this clinical research study is to learn if magnetic resonance imaging (MRI) with magnetic resonance spectroscopy (MRS) can show the effects of pre-surgical chemotherapy in breast cancer patients who are eligible to receive preoperative chemotherapy.

In this study, MRI will be used to determine the effects of pre-surgical chemotherapy on breast cancer. MRS looks at the chemical components of tissue. MRS may be helpful in understanding how pre-surgical chemotherapy works.

Before you can start treatment on this study, you will have "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. Blood (about 1 teaspoon) will be drawn for routine tests. Women who are able to have children must have a negative blood (about 1 teaspoon) pregnancy test.

If you are found to be eligible to take part in this study, you will have 3 MRI with MRS scans on both breast including the affected breast. The scans will be performed before chemotherapy, 21 days (plus or minus 3 days) after you start chemotherapy (Day 1 = your first day of chemotherapy), and at the end of the chemotherapy/before surgery. If you have never had an MRI scan before, you will be given the opportunity to watch a 10-minute video to prepare you for the procedure.

You will have specialized MRI scans: MRS, DCE, and DW. The DCE is a Dynamic Contrast Enhanced MRI. DCE-MRI is used to create a 3-D image of the breast tumor, so that the small blood vessels can be seen. The Diffusion-Weighted (DW) MRI may possibly be used to study the structure of tumor cells based on the movement of water molecules in tumor tissue.

For this, you will lie still on your stomach with your breasts positioned within the openings of the detector. A contrast drug, which helps the MRI scanner to show the breast lesion, will be injected through a needle in your vein. The procedure will take about 1 hour.

The tissues removed during the surgery will be collected as part of this study. Small pieces of tissues will be stained with special stains to give more information about the tumor (such as invasiveness, blood vessel supply, number of positive lymph nodes, tissue changes). Multiple sections of the tissues will be stained to make sure that all tissue areas of interest will be able to be compared with MRI/MRS images. The tissues then will be photographed and x-rayed.

You will be considered off-study 6 months after surgery. If you are unable to have surgery, you will be considered off-study 6 months after the last MRI with MRS.

This is an investigational study. The MRI with MRS scans are FDA approved and commercially available. The first and third scans will be part of routine patient care. The second scan is not part of routine care. Up to 28 participants will take part in this study. All will be enrolled at M. D. Anderson.

The tissues removed during surgery (mastectomy) will be collected as part of this study.

Non-Invasive Magnetic Resonance Imaging (MRI) and Magnetic Resonance Spectroscopy Techniques (MRS) for Assessing Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer

Non-Invasive MRI and MRS Techniques for Assessing Therapeutic Response to Pre-surgical Chemotherapy in Breast Cancer Patients

Quantitative measures of tissue function obtained non-invasively by dynamic contrast enhanced (DCE) MRI, diffusion-weighted (DW) MRI, and proton MR spectroscopy (1H MRS) techniques to assess effects of pre-surgical chemotherapy in breast cancer patients eligible for preoperative chemotherapy.

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Symptoms and General Pathology

Rare Diseases

Glioblastoma

Hypoxia

Gliosarcoma

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

Signs and Symptoms, Respiratory

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Temozolomide

Misonidazole

Antiprotozoal Agents

Antiparasitic Agents

Two weeks before initiation of chemoradiotherapy with temozolomide, patients undergo MRI (DSC, DCE,DWI and MRS) and PET scan using FMISO. A subset of 15 patients undergo FMISO PET scans approximately 1 week before chemoradiotherapy.

FMISO

Elizabeth Gerstner

This phase II trial is studying how well positron emission tomography (PET) scan using 18F-fluoromisonidazole works when given together with magnetic resonance imaging (MRI) ) in assessing tumor hypoxia in patients with newly diagnosed glioblastoma multiforme (GBM). Diagnostic procedures, such as MRI and PET scan using 18F-fluoromisonidazole (FMISO), may help predict the response of the tumor to the treatment and allow doctors to plan better treatment.

PRIMARY OBJECTIVES:

I. To determine the association of baseline FMISO PET uptake (hypoxic volume \[HV\]), highest tumor:blood ratio \[T/Bmax\]) and MRI parameters (Ktrans, CBV) with overall survival (OS) in participants with newly diagnosed GBM.

SECONDARY OBJECTIVES:

I. To determine the association of baseline FMISO PET uptake (HV, T/Bmax) and MRI parameters (Ktrans, CBV) with time to progression (TTP) and 6-month progression free survival (PFS-6) in participants with newly diagnosed GBM.

II. To assess the reproducibility of the baseline FMISO PET uptake parameters by implementing baseline "test" and "retest" PET scans (performed within 1 to 7 days of each other).

III. To assess the correlation between highest tissue:cerebellum ratio \[T/Cmax\] and T/Bmax at baseline.

IV. To assess the correlation between other MRI parameters (for example Gadolinium-enhanced T1-weighted (T1Gd), vessel caliber index (VCI), , CBV-S, apparent diffusion coefficient (ADC) , N-acetylaspartate (NAA) to choline (Cho) ratio, blood oxygenation level-dependent (BOLD), T2) and OS, TTP, and PFS-6.

OUTLINE: This is a multicenter study.

Two weeks before initiation of chemoradiotherapy with temozolomide, patients undergo MRI and PET scan using FMISO. A subset of 15 patients undergo FMISO PET scans approximately 1 week before chemoradiotherapy. Blood samples are collected at baseline and periodically during study to compare image measures of tissue uptake of FMISO to blood concentrations. Tumor samples are collected from diagnostic biopsy or surgery for analysis of tumor hypoxic markers and methylguanine methyl transferase by immunohistochemical and Polymerase chain reaction (PCR) assays.

After completion of study therapy, patients are followed up every 3 months for up to 5 years.

MRI and PET/FMISO In Assessing Tumor Hypoxia in Patients With Newly Diagnosed Glioblastoma Multiforme

Multicenter, Phase II Assessment of Tumor Hypoxia in Glioblastoma Using 18F-Fluoromisonidazole (FMISO) With PET and MRI

Disease progression was defined by Macdonald criteria. Survival and Progression were evaluated every 3months and at the end of study (up to 5 years) and time to event evaluated.

The FMISO image data were normalized by the average blood activity to produce pixel level tissue-to-blood ratio (T/B) values for all image slices. And the severity of the hypoxia was determined by the pixel with the maximum T/B value (TBmax).

FMISO SUVpeak was determined as the average SUV from a 1 cm circular ROI centered over the hottest pixel. Since FMISO selectively binds to hypoxic tissues, SUVpeak within a region provides a measure of tumor hypoxia.

The hypoxic volume (HV) was determined as the volume of pixels in the tumor on in the FMISO\\PET with a tumor to blood activity ratio ≥ 1.2.

HV is a measure of the spatial extent of tumor hypoxia (in milliliters)

Apparent Diffusion Coefficient (ADC) measures water diffusion through tissue (mm\^2/s). Cerebral infarction leads to diffusion restriction resulting in a low ADC signal in the infarcted area.

A double Gaussian mixed model was fit to the ADC histogram and the mean of the lower and the mean of the higher ADC curves were evaluated

Relative cerebral blood volume (RCBV) maps, computed from the integral of ∆R2\*(t), were corrected for leakage effects and normalized to normal appearing white matter (nRCBV); nRCBV provides a measure of tumor vasculature Cerebral blood flow (CBF) maps were was normalized to the mean of the region of interest (ROI) in normal appearing white matter (nCBF); nCBF provides a measure of vascular permeability and perfusion

ktrans is a measure of vascular permeability and reflects the rate of gadolinium moves from plasma to extravascular extracellular space (predominantly though blood flow and capillary leakage), which can be represented by the mean or median rate.

Mean \& Median ktrans within subject were computed using a matrix-based linearization method to fit tissue ∆R1(t) to the extended Tofts model.

The mean across subjects is presented below (Mean (Mean-ktrans) and Mean(Median-Ktrans))

Overall Survival (OS) was evaluated every 3 months through end of the study (up to 5 years). A variety of continuous quantitative (functional) imaging features measuring abnormal tumor vasculature (MRI) and hypoxia (FMISO) were evaluated at baseline for their association with Survival time.

Features include

PET Hypoxia measures:

Peak standardized uptake values (SUVpeak); maximum tumor:blood ratio (T/Bmax); and Hypoxia Volume (HV)

DCE MRI perfusion measures:

Mean/median volume transfer constant for gadolinium between blood plasma and the tissue extravascular extracellular space (ktrans)

DSC MRI tumor vasculature:

Normalized Relative cerebral blood volume (nRCBV); and Cerebral blood flow (CBF)

DWI MRI magnitude of diffusion of water through tissue (cell density):

Apparent diffusion coefficient (ADC) using low and high Gaussian distributions

Disease progression was defined by Macdonald criteria. PFS was evaluated every 3months through the end of study (up to 5yrs), features were measured at baseline.

Quantitative imaging features measuring abnormal tumor vasculature (MRI) and hypoxia (FMISO) were evaluated for their association with TTP (cox model) and to discriminate between responders and non-responders at 6 and 9 mos (PFS6 and PFS9) (logistic) Features include

PET Hypoxia measures:

Peak standardized uptake values (SUVpeak); maximum tumor:blood ratio (T/Bmax); and Hypoxia Volume (HV)

DCE MRI perfusion measures:

Mean/median volume transfer constant for gadolinium between blood plasma and the tissue extravascular extracellular space (ktrans)

DSC MRI tumor vasculature:

Normalized Relative cerebral blood volume (nRCBV); and Cerebral blood flow (CBF)

DWI MRI magnitude of diffusion of water through tissue (cell density):

Apparent diffusion coefficient (ADC) using low and high Gaussian distributions

Reproducibility, defined as the variation of repeated measurements in an experiment performed under the same conditions, will be measured as the within subject coefficient of variation with upper an lower repeatability coefficients (LRC, URC) computed as percents from log-transformed data, per Velaquez, et al (J Nucl Med. 2009 Oct;50(10):1646-54. doi: 10.2967/jnumed.109.063347. Epub 2009 Sep 16. PMID: 19759105 ).

Where Within Subject Coefficient of Variation (wCV) is a percentage defined as wCV(%)=100\* (exp( SD\[ld\]/√2) - 1)

and LRC and URC are calculated as: RC=100 (exp(±1.96 SD\[ld\]) -1).

here SD\[ld\] is the standard deviation of the difference of the log-transformed PET measurements. These bounds provide an estimate of the lower and upper bounds of percent change observed between scans for each measurement.

Pearson correlation coefficient will be used to quantify the correlation between T/Bmax, the maximum tissue-to-blood ratio activity value, and T/Cmax, the tissue-to-cerebellum activite value Since T/Cmax does not requiring blood sampling and is image derived, a high correlation would indicate that T/Cmax could be an advantageous surrogate for T/Bmax.

Correlation between MRS markers and MR imaging markers and PET markers of tumor hypoxia

MRS markers include:

NAA/Cho, Cho/Cr, Lac/Cr, and Lac/NAA measured within tumor and at the periphery.

MR imaging markers of vascularity include: CBV, CBF, and ktrans PET tumor hypoxia marker: SUVmax

The adverse reporting period is 10 half-lives after the administration of the investigational imaging radiotracer, with a minimum reporting period of at least 24hours post injection. Participants must be reassessed for events between 24 and 72hours post injection.

Patients with Newly diagnosed GBM scheduled to have FMISO PET/CT two weeks before initiation of chemoradiotherapy with temozolomide.

Evaluable Cases

Patients with Newly diagnosed GBM who have FMISO PET/CT Imaging two weeks before initiation of chemoradiotherapy with temozolomide.

Diagnostic PET (Using FMISO)

Patients with Newly diagnosed GBM who have FMISO PET/CT and Dynamic Contrast Enhanced (DCE) MR Imaging two weeks before initiation of chemoradiotherapy with temozolomide.

Diagnostic MRI (DCE MRI)

Patients with Newly diagnosed GBM who have FMISO PET/CT and Dynamic Susceptibility Contrast Enhanced (DSC) MR Imaging two weeks before initiation of chemoradiotherapy with temozolomide.

Diagnostic MRI (DSE MRI)

Patients with Newly diagnosed GBM who have FMISO PET/CT and Diffusion-Weighted Imaging (DWI) MR Imaging two weeks before initiation of chemoradiotherapy with temozolomide.

Diagnostic MRI (DWI MRI)

42 eligible, consented patients with newly diagnosed GBM who received both FMISO-PRT and MRI imaging two weeks before initiation of chemoradiotherapy with temozolomide

Newly Diagnosed Glioblastoma Multiforme Patients

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Median Tumor Volume

Patients with newly diagnosed GBM who received both FMISO-PRT imaging two weeks before initiation of chemoradiotherapy with temozolomide

Donna Harfeil, Director of Protocol Management

FMISO selectively binds to hypoxic tissues so that SUVpeak within a region provides a measure of tumor hypoxia.:

This marker was modeled with a univariate Cox regression model for overall survival (OS) time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported.

T/Bmax is the pixel in the tumor region with the maximum tumor:blood ratio (T/Bmax) and T/Bmax depicts the magnitude of the hypoxia TBmax was modeled with a univariate Cox regression model for OS time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported. The study was designed to enroll 46 evaluable participants to detect a log hazard ratio of 1.279 for TBmax with HV as a covariate with a 50% event rate

Hypoxia Volume (HV) depicts the volume of tumor that has crossed the threshold for hypoxia.

Hypoxic Volume (HV) was modeled with a univariate Cox regression model for overall survival (OS) time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported.

ktrans reflects the rate of gadolinium moves from plasma to extravascular extracellular space (predominantly though blood flow and capillary leakage).

Mean ktrans were computed using a matrix-based linearization method to fit tissue ∆R1(t) to the extended Tofts model Mean ktrans was modeled with a univariate Cox regression model for overall survival (OS) time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported.

ktrans reflects the rate of gadolinium moves from plasma to extravascular extracellular space (predominantly though blood flow and capillary leakage).

Median ktrans were computed using a matrix-based linearization method to fit tissue ∆R1(t) to the extended Tofts model.

Median ktrans was modeled with a univariate Cox regression model for overall survival (OS) time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported.

Relative cerebral blood volume (RCBV) maps, computed from the integral of ∆R2\*(t), were corrected for leakage effects and normalized to normal appearing white matter (nRCBV); nRCBV provides a measure of tumor vasculature and was modeled with a univariate Cox regression model for overall survival (OS) time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported.

cerebral blood flow (CBF) maps were was normalized to the mean of the region of interest (ROI) in normal appearing white matter to produce the nCBF and provide another measure of vascular permeability and perfusion nCBF was modeled with a univariate Cox regression model for overall survival (OS) time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported.

Apparent Diffusion Coefficient (ADC) measures water diffusion through tissue. Cerebral infarction leads to diffusion restriction resulting in a low ADC signal in the infarcted area. A double Gaussian mixed model was fit to the ADC histogram and the mean of the lower ADC curve, was modeled with a univariate Cox regression model for overall survival (OS) time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported.

Apparent Diffusion Coefficient (ADC) measures water diffusion through tissue. Cerebral infarction leads to diffusion restriction resulting in a low ADC signal in the infarcted area. A double Gaussian mixed model was fit to the ADC histogram and the mean of the higher ADC curve, was modeled with a univariate Cox regression model for overall survival (OS) time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported.

OS-1 Alive

OS-1 Death

42 participants with imaging (FMISO-PET, DCE/DSC/DWI MRI)

Evaluable

Quantitative PET measurements Hypoxic Volume (HV) Max tumor:blood ratio (TBmax) Peak Standardized uptake Values (SUVpeak)

FMISO-PET

Quantitative DSC measurements:

Normalized rCBV \[Relative cerebral blood volume\] Normalized rCBF\[Relative cerebral blood flow\]

DSC MRI

Quantitative DCE measurements Mean vascular permeability (ktrans) Median Ktrans

DCE MRI

Apparent diffusion coefficient (ADC) Low and High

DWI-MRI

FMISO-PET identifies the primary analysis population containing participants with interpretable FMISO images.The Evaluable study population consisted of enrolled GBM patients having an FMISO-PET procedure. Additional groups include functional MRI, with available/interpretable images.

Association of Baseline FMISO PET and MRI Features With OS as Assessed Using Cox-regression Model

FMISO selectively binds to hypoxic tissues so that SUVpeak within a region provides a measure of tumor hypoxia.

This marker was modeled with a univariate Cox regression model for Progression Free Survival time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported.

T/Bmax is the pixel in the tumor region with the maximum tumor:blood ratio (T/Bmax) and T/Bmax depicts the magnitude of the hypoxia TBmax was modeled with a univariate Cox regression model for PFS time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported.

Hypoxia Volume (HV) depicts the volume of tumor that has crossed the threshold for hypoxia.

Hypoxic Volume (HV) was modeled with a univariate Cox regression model for PFS time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported.

ktrans reflects the rate of gadolinium moves from plasma to extravascular extracellular space (predominantly though blood flow and capillary leakage).

Mean ktrans were computed using a matrix-based linearization method to fit tissue ∆R1(t) to the extended Tofts model.

Mean ktrans was modeled with a univariate Cox regression model for PFS time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported.

ktrans reflects the rate of gadolinium moves from plasma to extravascular extracellular space (predominantly though blood flow and capillary leakage).

Median ktrans were computed using a matrix-based linearization method to fit tissue ∆R1(t) to the extended Tofts model.

Median ktrans was modeled with a univariate Cox regression model for PFS time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported.

Relative cerebral blood volume (RCBV) maps, computed from the integral of ∆R2\*(t), were corrected for leakage effects and normalized to normal appearing white matter (nRCBV); nRCBV provides a measure of tumor vasculature and was modeled with a univariate Cox regression model for PFS time.

The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported.

cerebral blood flow (CBF) maps were was normalized to the mean of the region of interest (ROI) in normal appearing white matter to produce the nCBF and provide another measure of vascular permeability and perfusion.

nCBF was modeled with a univariate Cox regression model for PFS time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported.

Logistic regression for SUVpeak to predict PFS6

TBmax was modeled with a univariate logistic regression model for PFS6.

Hypoxic Volume (HV) was modeled with a logistic regression model for 6month progression free survival (PFS6) .

Mean ktrans were computed using a matrix-based linearization method to fit tissue ∆R1(t) to the extended Tofts model.

Mean ktrans was modeled with a univariate logistic regression model for PFS6.

Median ktrans were computed using a matrix-based linearization method to fit tissue ∆R1(t) to the extended Tofts model.

Median ktrans was modeled with a univariate logistic regression model for PFS6

Relative cerebral blood volume (RCBV) maps were corrected for leakage effects and normalized to normal appearing white matter (nRCBV).

nRCBV was modeled with a univariate logistic regression model for PFS6.

cerebral blood flow (CBF) maps were was normalized to the mean of the region of interest (ROI) in normal appearing white matter to produce the nCBF.

nCBF was modeled with a univariate logistic regression model for PFS6.

Apparent Diffusion Coefficient (ADC) low values were modeled with a univariate logistic regression model for PFS6

Apparent Diffusion Coefficient (ADC) high values were modeled with a univariate Logistic regression model for PFS6

FMISO selectively binds to hypoxic tissues so that SUVpeak within a region provides a measure of tumor hypoxia.

Receiver Operating Characteristic(ROC) analysis was perform to determine the accuracy of this marker to predict PFS9.

T/Bmax is the pixel in the tumor region with the maximum tumor:blood ratio (T/Bmax) and T/Bmax depicts the magnitude of the hypoxia.

Receiver Operating Characteristic(ROC) analysis was perform to determine the accuracy of this marker to predict PFS9.

Hypoxia Volume (HV) depicts the volume of tumor that has crossed the threshold for hypoxia.

Receiver Operating Characteristic(ROC) analysis was perform to determine the accuracy of this marker to predict PFS9.

mean ktrans reflects the rate of gadolinium moves from plasma to extravascular extracellular space (predominantly though blood flow and capillary leakage).

Receiver Operating Characteristic(ROC) analysis was perform to determine the accuracy of mean ktrans to predict PFS9.

Median ktrans reflects the rate of gadolinium moves from plasma to extravascular extracellular space (predominantly though blood flow and capillary leakage).

Receiver Operating Characteristic(ROC) analysis was perform to determine the accuracy of Median ktrans to predict PFS9.

nRCBV provides a measure of tumor vasculature Receiver Operating Characteristic(ROC) analysis was perform to determine the accuracy of this marker to predict PFS9.

nCBF provides a measure of vascular permeability and perfusion. Receiver Operating Characteristic(ROC) analysis was perform to determine the accuracy of this marker to predict PFS9.

6 month Progression Status

9 Month Progression Status

Association of Baseline FMISO PET and MRI Features With Time-to-Progression (TTP)

SUVmax : Average across all lesions by participant

SUVmax : Maximum across all lesions by participant

SUVmax : Target Lesion

SUVpeak: Average across all lesions by participant

SUVpeak: Maximum across all lesions by participant

SUVpeak: Target Lesion

Participants with two FMISO PET scans within 1 to 7 days of each other and prior to Visit 2 to test reproducibility of FMISO PET removing 5 participants with protocol variations which could affect the SUV measurements

FMISO Reproducibility

Analysis will be performed SUVmax and SUV Peak, average and maximum values, across patients and by target tumor.

Reproducibility of the Baseline FMISO PET Uptake Parameters as Assessed by Baseline "Test" and "Retest" PET Scans

Correlation Between T/Cmax and T/Bmax

NAA/Cho Tumor

NAA/Cho Periphery

Cho/Cr Tumor

Cho/Cr Periphery

Lac/Cr Tumor

Lac/Cr Periphery

Lac/NAA Tumor

Lac/NAA Periphery

17 participants with measured MRS markers and nRCBV: relative cerebral blood volume, corrected for leakage effects and normalized to normal-appearing white matter;

nrCBV

17 participants with measured MRS markers and nCBF: cerebral blood flow, normalized to normal-appearing white matter;

nCBF

17 participants with measured MRS markers and k-trans: vascular permeability

Median K-trans

17 participants with measured MRS markers and SUVmax: standardized uptake value

SUV Max

Seventeen participants from four sites had analyzable 3D MRSI datasets acquired on Philips, GE or Siemens scanners at either 1.5T or 3T. MRSI data were analyzed using LCModel to quantify metabolites N-acetylaspartate (NAA), creatine (Cr), choline (Cho), and lactate (Lac)

Correlation Between MRS Markers and MR Imaging Markers of Vascularity as Well as Between MRS Markers and PET Markers of Tumor Hypoxia

Median OS time

Median PFS

Overall and Progression Free Survival

SUVpeak

T/Bmax

Quantitative PET measurements Max tumor:blood ratio (TBmax) Peak Standardized uptake Values (SUVpeak)

SUVpeak and T/Bmax as Measures of Tumor Hypoxia

Hypoxic Volume as a Measure of Tumor Hypoxia

High

Participants having a usable FMISO\\PET and DWI\\MRI scans

DWI Apparent Diffusion Coefficient (ADC)

nRCBV

Evaluable participants with both usable FMISO\\PET and DSC\\MRI.

Normalized Relative Cerebral Blood Volume (nRCBV) and Normalized Cerebral Blood Flow (nCBF)

Mean kTrans

Median kTrans

Evaluable patients with usable FMISO\\PET and DCE\\MRI

Summary of Mean and Median Ktrans Across Participants.

Patients with Newly diagnosed GBM scheduled to have FMISO Positron Emission Tomography (PET) two weeks before initiation of chemoradiotherapy with temozolomide, with diagnostic DCE/DSE/DWI MRI

Overall Study

Nervous System Diseases

Neoplasm Metastasis

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

MRI at timepoints given above, neuropsychological testing after surgery, but before radiotherapy or chemotherapy.

Neuropsychological testing month 3 during treatment. Neuropsychological testing after 1 year. Neuropsychological testing after 2 years.

MRI, neuropsychological evaluation, blood sampling

Pia Maly Sundgren, MD. PhD

The main purposes with this trial is to investigate the potential of MRI with diffusion and blood volume, flow in brain to diagnose and to measure treatment effects in patients with intracranial tumors, especially gliomas and metastases in a prospective trial, to evaluate the possibilities to individually adjusted treatment in this category of patients depending on treatment outcomes measured by MRI, to perform clinical follow up in connection with MRI to evaluate a correlation and to perform testing of cognitive ability before, during, and after treatment and to investigate if given treatment causes any decrease in the patients habitual state.

Treatment Effects Inclusive Cognitive Impact and Possibilities to Individually Adjusted Treatment in Patients With Intracranial Tumors With Clinical, Neuropsychological and Imaging Parameters

Treatment Effects Inclusive Cognitive Impact and Possibilities to Individually Adjusted Treatment in Patients With Intracranial Tumors With Clinical, Neuropsychological and Imaging Parameters.

Neuropsychological testing to evaluate the correlation between MRI results and neuropsychological status in participating patients. This applies for 80 patients of 150 of the patient population.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Correlation Between MRS (Magnetic Resonance Spectroscopy) and Tumor Response to Radiation Therapy in Breast Cancer	NCT01428739	Breast Cancer	MRS	18 Years -	AHS Cancer Control Alberta
Correlation Between MRS (Magnetic Resonance Spectroscopy) and Tumor Response to Radiation Therapy in Breast Cancer	NCT01428739	Breast Cancer	MRS	18 Years -	AHS Cancer Control Alberta
Non-Invasive Magnetic Resonance Imaging (MRI) and Magnetic Resonance Spectroscopy Techniques (MRS) for Assessing Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer	NCT00490503	Breast Cancer	Magnetic Resona... Magnetic Resona...	18 Years -	M.D. Anderson Cancer Center
MRI and PET/FMISO In Assessing Tumor Hypoxia in Patients With Newly Diagnosed Glioblastoma Multiforme	NCT00902577	Adult Giant Cel... Adult Glioblast... Adult Gliosarco...	FMISO MRI PET MRS	18 Years -	National Cancer Institute (NCI)
Treatment Effects Inclusive Cognitive Impact and Possibilities to Individually Adjusted Treatment in Patients With Intracranial Tumors With Clinical, Neuropsychological and Imaging Parameters	NCT01674582	Intracranial Tu...	MRI, neuropsych...	18 Years -	Lund University Hospital
Monitoring Anti-angiogenic Therapy in Brain Tumors by Advanced MRI	NCT02843230	Glioblastoma	Avastin Lomustine Temozolomide MRI MRS DSC	18 Years -	Massachusetts General Hospital
Metformin for Ectopic Fat Deposition and Metabolic Markers in Polycystic Ovary Syndrome (PCOS)	NCT02500147	Polycystic Ovar... Non-Alcoholic F... Metabolic Syndr...	Metformin Placebo	13 Years - 25 Years	Columbia University
NAFLD in Adolescents and Young Adults With PCOS	NCT02506946	Polycystic Ovar... Non-Alcoholic F... Metabolic Syndr...		14 Years - 25 Years	Columbia University
Examination of Changes on Magnetic Resonance Imaging (MRI) and Magnetic Resonance Spectroscopy (MRS) in Patients Who Receive Gliadel Wafers During Initial Surgery for Glioblastoma Multiforme. Response or Failure to Gliadel Wafers for Subjects With Glioblastoma Multiforme.	NCT00645385	Glioblastoma Mu... Anaplastic Astr... Anaplastic Olig...	MRS Spectroscop...	18 Years - 85 Years	Weill Medical College of Cornell University

Spots Global Cancer Trial Database for mrs

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

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