Neoplasms

Nervous System Diseases

All Conditions

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Anti-Infective Agents

Antineoplastic Agents

All Drugs and Chemicals

Misonidazole

Antiprotozoal Agents

Antiparasitic Agents

Participants receive FMISO intravenously (IV). Participants also undergo dynamic PET/computed tomography (CT) or PET/MRI over 120 minutes beginning 1 minute prior to FMISO injection, and static PET/CT or PET/MRI over 20-40 minutes approximately 90 minutes after FMISO injection. Participants then undergo a retest examination within 7 days. Participants may undergo 2 more PET/MRI or PET/CT scans no sooner than every 4 weeks. Supplemental oxygen may be administered to effect MRI signal.

¹⁸F-Fluoromisonidazole

Computed Tomography

Magnetic Resonance Imaging

Positron Emission Tomography

Oxygen Therapy

Ramon Barajas

This phase II trial studies how well ¹⁸F- fluoromisonidazole (FMISO) works with positron emission tomography (PET)/magnetic resonance imaging (MRI) in assessing participants with malignant (cancerous) brain tumors. FMISO provides information about the oxygen levels in a tumor, which may affect how the tumor behaves. PET/MRI imaging produces images of the brain and how the body functions. FMISO PET/MRI may help investigators see how much oxygen is getting in the brain tumors.

PRIMARY OBJECTIVES:

I. Determine the feasibility of obtaining ¹⁸F- fluoromisonidazole (FMISO) PET (hypoxic volume and tumor to blood background values \[T/B\]) and dynamic susceptibility contrast enhanced (DSC) \& diffusion-weighted imaging (DWI) MRI measures in patients with intracranial brain tumors.

II. Determine if MRI contrast-enhancement and hypoxic volume are imaging profiles of glioblastoma immunotherapy-mediated pseudoprogression or true progression in a clinical trial.

SECONDARY OBJECTIVE:

I. Determine the feasibility of baseline and follow-up FMISO PET and MR imaging co-registration.

TERTIARY OBJECTIVE:

I. Determine the reproducibility of the baseline FMISO PET imaging metrics as assessed by baseline "test" and "retest" experiments.

OUTLINE:

Participants receive FMISO intravenously (IV). Participants also undergo dynamic PET/computed tomography (CT) or PET/MRI over 120 minutes beginning 1 minute prior to FMISO injection, and static PET/CT or PET/MRI over 20-40 minutes approximately 90 minutes after FMISO injection. Participants then undergo a retest examination within 7 days. Participants may undergo 2 more PET/MRI or PET/CT scans no sooner than every 4 weeks. Supplemental oxygen may be administered to effect MRI signal.

After conclusion of the diagnostic tests, participants are followed for up to 5 years.

Feasibility of FMISO in Brain Tumors

Feasibility of [¹⁸F]-Fluoromisonidazole (FMISO) in Assessment of Malignant Brain Tumors

Assessed as a factor of generating quantitative positron emission tomography (PET)/magnetic resonance imaging (MRI) metrics (intra-tumoral FMISO tumor to blood \[T/B\] level, hypoxic volume, dynamic susceptibility contrast enhanced \[DSC\], and diffusion-weighted imaging \[DWI\] values, and tissue oxygen maps). Images generated during the administration of oxygen will be used to generate tissue oxygen maps of the brain. Following completion of cohort enrollment, the generation of each quantitative PET/MRI metric will be independently scored as a dichotomous variable; successful or non-successful. Proportional assessment will be performed to assess for project feasibility. The successful generation of PET/MRI metrics in 85% of the initial cohort successfully imaged will need to be achieved for the imaging modality to be deemed feasible for this study. The estimated proportion of success rate for each metric along with the corresponding 95% binomial confidence interval will be provided.

Measured by Response assessment in neuro-oncology criteria sum product diameter assessment. The primary outcomes for this aim are enhancement mismatch ratio and hypoxic volume. Differences in imaging metrics will be evaluated using two sample t-test. If normal assumption is not satisfied, data transformation, or 95% confidence intervals based on bootstrapping method will be used. Exploratory analysis will assess diagnostic performance of imaging metrics (mismatch ratio and hypoxic volume) to identify pseudoprogression at earlier imaging dates.

The generation of co-registered imaging data sets will be independently scored as a dichotomous variable; successful or non-successful (\< 10mm versus \[vs.\] \> 10mm alignment error). Proportional assessment will be performed to assess for project feasibility. The estimated proportion along with the corresponding 95% binomial confidence interval will be provided.

National Cancer Institute (NCI)

Oregon Health and Science University

Weill Cornell University

OHSU Knight Cancer Institute

Principal Investigator

Symptoms and General Pathology

Hypoxia

Patients receive supplemental oxygen while undergoing standard of care MRI.

This clinical trial evaluates the feasibility of performing oxygen-enhanced magnetic resonance imaging (MRI) to generate hypoxia maps in patients with intracranial tumors. Decreased levels of oxygen (hypoxia) is a hallmark of malignant brain tumors. Chronic hypoxia is a stimulator of blood vessel formation, which is required for tumor growth and spread. Hypoxia also limits the effectiveness of radiation and chemotherapy. MRI is an imaging technique that uses radiofrequency waves and a strong magnetic field rather than x-rays to provide detailed pictures of internal organs and tissues. The administration of inhaled oxygen allows for an increased MRI signal effect size. Oxygen-enhanced MRI may be a non-invasive method that can physiologically estimate tissue hypoxia. With a better understanding of the extent of tumor hypoxia, more effective and patient-specific therapies could be devised to halt malignant tumor growth.

PRIMARY OBJECTIVE:

I. Determine the feasibility of generating hypoxia maps from oxygen MRI.

SECONDARY OBJECTIVES:

I. Evaluate the association between oxygen MRI hypoxia maps generated using T2\* and T1 MRI sequences.

II. Evaluate the association between oxygen MRI hypoxia maps and progression free survival.

OUTLINE:

Patients receive supplemental oxygen while undergoing standard of care MRI.

Oxygen-Enhanced MRI for Generating Hypoxia Maps in Patients With Intracranial Tumors

Feasibility of Oxygen Enhanced MRI in Assessment of Malignant Brain Tumors

Evaluated to determine the feasibility of obtaining oxygen MRI hypoxia maps. Following completion of cohort enrollment, the generation of each hypoxia map will be independently scored as a dichotomous variable; successful or non-successful. The successful generation of a hypoxia map from either a T1 or T2\* approach in 85% of the cohort of patients will need to be achieved for the imaging modality to be deemed feasible for the purposes of this study. Will provide the estimated proportion of success rate for each metric along with the corresponding 95% exact confidence interval.

Evaluated to determine the feasibility of obtaining oxygen MRI hypoxia maps.

Will determine the association between oxygen MRI hypoxia maps generated using T2\* and T1 MRI sequences. Assessed using Pearson's correlation coefficient.

Will perform Kaplan Meier analysis of progression free survival stratified by median T1 and T2\* hypoxic volume to determine the association between oxygen MRI hypoxia maps and progression free survival. A Cox regression model will also be explored by treating hypoxic volume as a continuous variable.

Respiratory Tract (Lung and Bronchial) Diseases

Dyspnea

Respiration Disorders

Respiratory Tract Diseases

Signs and Symptoms, Respiratory

Patients receive high-flow oxygen via nasal prongs during a structured stationary bicycle exercise session.

Patients receive high-flow air via nasal prongs during a structured stationary bicycle exercise session

Patients receive low-flow oxygen via a nasal cannula during a structured stationary bicycle exercise session.

Patients receive low-flow air via a nasal cannula during a structured stationary bicycle exercise session.

Quality-of-Life Assessment

Questionnaire Administration

Respiratory Therapy

David Hui

This randomized phase II trial studies how well high-flow oxygen works in reducing difficulty breathing during exercise (exertional dyspnea) in patients with cancer. Dyspnea is linked to decreased lung function, quality of life, and survival. High-flow oxygen is a device that delivers heated and humidified oxygen through the nose. This may be effective in reducing dyspnea, and may help patients' lungs function better and improve their quality of life.

PRIMARY OBJECTIVES:

I. Obtain preliminary estimates of the effect size of oxygen and high flow rate on exertional dyspnea (modified Borg Scale adjusted for work rate and baseline dyspnea).

SECONDARY OBJECTIVES:

I. Determine the completion rate of a randomized controlled trial of exertional dyspnea in cancer patients.

II. Obtain preliminary estimates of the effects of oxygen and flow rate on physiologic function (respiratory rate and oxygen saturation) and exercise capacity (work rate and exercise duration).

OUTLINE: All patients undergo a baseline structured exercise session with air. Patients are then randomized to 1 of 4 treatments for a second session approximately 3 days later.

ARM I: Patients receive high-flow oxygen via nasal prongs during a structured stationary bicycle exercise session.

ARM II: Patients receive high-flow air via nasal prongs during a structured stationary bicycle exercise session.

ARM III: Patients receive low-flow oxygen via a nasal cannula during a structured stationary bicycle exercise session.

ARM IV: Patients receive low-flow air via a nasal cannula during structured stationary bicycle exercise session.

High-Flow Oxygen in Reducing Shortness of Breath Caused by Exercise in Patients With Cancer

High-Flow Oxygen for Exertional Dyspnea in Cancer Patients

Assessed Dyspnea using the Modified Borg Scale Dyspnea Intensity that ranges from 0 ("no shortness of breath") to 10 ("worst possible shortness of breath") at Isotime. Measured the mean difference of Modified Borg Scale Dyspnea Intensity at isotime between the second exercise test (in which all patients received Low Flow Oxygen) and the third exercise tests (in which all patients received the assigned intervention).

Dyspnea unpleasantness was measured using the Modified Borg Scale Dyspnea Intensity that ranges from 0 ("no shortness of breath") to 10 ("worst possible shortness of breath"). Dyspnea intensity was measured every minute. The number of minutes varied by patient, per test. It was measured as pairwise difference of slope (taking 'low flow air' arm as a reference). This linear mixed model was constructed based on the following: Dyspnea Unpleasantness at third test = Minutes + Study Arm + Study Arm\*Minutes + Total work rate + Slope of Dyspnea Unpleasantness and Minutes at Second test + Minutes at second test.

Leg discomfort was measured using the Modified Borg Scale Leg discomfort that ranges from 0 ("no discomfort") to 10 ("worst possible discomfort") during the constant work exercise of third test. Leg discomfort was measured every minute. The number of minutes varied by patient, per test. It was measured as pairwise difference of slope (taking 'low flow air' arm as a reference). This linear mixed model was constructed based on the following: Leg Discomfort at third test = Minutes + Study Arm + Study Arm\*Minutes + Total work rate + Slope of Leg Discomfort and Minutes at Second test + Minutes at Second test.

The Exercise endurance was measured as a mean duration of constant work in minutes during third test. It was measured as pairwise comparison of mean difference of exercise duration (taking 'low flow air' as a reference). This linear mixed model was constructed based on the following: Time at third test = Study Arm + Minutes at Second test. Detail output from the mixed models

Adverse effects related to supplemental oxygen use were assessed using a numeric rating scale from 0 (not at all) to 10 (worst possible) before and after the study intervention. The mean change was measured before and after the 3rd test ranging between -10 (improvement) and +10 (deterioration).

M.D. Anderson Cancer Center

In this protocol, the Adverse events were not measured as an absolute number. It was measured as a numeric rating score from 0 (not at all) to 10 (worst possible). So there are no Adverse events numbers in the Adverse Events section. As per the protocol, Adverse events were considered as a secondary outcome. Please see 'Adverse Events' under 'Outcome Measure.'

High Flow Oxygen were delivered between 20 and 70 L/min

High Flow Oxygen

High Flow Air were delivered between 20 and 70 L/min

High Flow Air

Low Flow Oxygen were delivered at 2 L/min

Low Flow Oxygen

Low Flow Air

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Mesothelioma

Non Small Cell Lung Cancer

Small Cell Lung Cancer

Other

Cancer Type

Localized

Locally advanced

Metastatic

Cancer Stage

COPD

Heart Failure

Asthma

Comorbidities

The data is provided for 44 participants who completed the study.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Feasibility of FMISO in Brain Tumors	NCT03649880	Malignant Brain...	¹⁸F-Fluoromison... Computed Tomogr... Magnetic Resona... Positron Emissi... Oxygen Therapy	18 Years -	OHSU Knight Cancer Institute
Oxygen-Enhanced MRI for Generating Hypoxia Maps in Patients With Intracranial Tumors	NCT05904704	Intracranial Ne...	Magnetic Resona... Oxygen Therapy	18 Years -	OHSU Knight Cancer Institute
Feasibility of FMISO in Brain Tumors	NCT03649880	Malignant Brain...	¹⁸F-Fluoromison... Computed Tomogr... Magnetic Resona... Positron Emissi... Oxygen Therapy	18 Years -	OHSU Knight Cancer Institute
Oxygen-Enhanced MRI for Generating Hypoxia Maps in Patients With Intracranial Tumors	NCT05904704	Intracranial Ne...	Magnetic Resona... Oxygen Therapy	18 Years -	OHSU Knight Cancer Institute
Feasibility of FMISO in Brain Tumors	NCT03649880	Malignant Brain...	¹⁸F-Fluoromison... Computed Tomogr... Magnetic Resona... Positron Emissi... Oxygen Therapy	18 Years -	OHSU Knight Cancer Institute
High-Flow Oxygen in Reducing Shortness of Breath Caused by Exercise in Patients With Cancer	NCT02357134	Dyspnea Malignant Neopl...	Oxygen Therapy Oxygen Therapy Quality-of-Life... Questionnaire A... Respiratory The... Respiratory The...	18 Years -	M.D. Anderson Cancer Center

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