Neoplasms

Symptoms and General Pathology

All Conditions

Nervous System Diseases

Neoplasm Metastasis

Necrosis

Disease Progression

Disease Susceptibility

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Participants undergo diagnostic magnetic resonance imaging (MRI) with and without contrast and treatment planning dynamic susceptibility contrast-MRI (DSC-MRI) series before receiving SRS at 4-6 weeks after SRS, and then every 3 months unless clinically indicated sooner.

Dynamic Susceptibility Contrast-MRI (DSC-MRI)

Magnetic Resonance Imaging (MRI)

Hui-Kuo Shu, MD, PhD

This trial studies how well dynamic susceptibility contrast-magnetic resonance imaging (MRI) works in determining radiation necrosis and tumor progression in participants with cancer that has spread to the brain and are being treated with radiation therapy. Diagnostic procedures, such as dynamic susceptibility contrast-MRI, may improve the ability to determine indeterminate post-treatment changes seen on imaging after radiation therapy.

PRIMARY OBJECTIVE:

I. To prospectively determine the sensitivity and specificity of dynamic susceptibility contrast (DSC)-MRI parameters in detecting tumor recurrence versus radiation necrosis for brain metastases treated with stereotactic radiosurgery (SRS).

SECONDARY OBJECTIVES:

I. To correlate radiographic diagnoses with pathologic diagnoses when surgical resection is clinically indicated.

II. To correlate baseline relative cerebral blood volume (rCBV) values and other hemodynamic parameters with tumor primary histology.

III. To assess overall survival, local failure, distant brain failure and neurologic death.

OUTLINE:

Participants undergo a diagnostic MRI with and without contrast and treatment planning DSC perfusion MRI series before receiving SRS at 4-6 weeks after SRS, and then every 3 months unless clinically indicated sooner.

Utility of Perfusion MRI to Detect Radiation Necrosis in Patients With Brain Metastases

Diagnostic Accuracy of Dynamic Susceptibility Contrast (DSC) Perfusion MRI to Determine Radiation Necrosis Versus Tumor Progression in Brain Metastases Treated With Stereotactic Radiosurgery

Image processing will occur in a blinded manner using nordicICE software (NordicNeuroLab AS, Bergen, Norway). Signal-intensity curves will be created per voxel. Regions of interest will be designated around the contrast enhancing lesion as seen on T1-post contrast MR. An additional contralateral area of normal-appearing white matter will be designated in the same axial plane to standardize the data. rCBV is calculated as the ratio of the CBV within the enhancing region to the CBV within the contralateral normal-appearing white matter.

Image processing will occur in a blinded manner using nordicICE software (NordicNeuroLab AS, Bergen, Norway). Signal-intensity curves will be created per voxel. Regions of interest will be designated around the contrast enhancing lesion as seen on T1-post contrast MR. An additional contralateral area of normal-appearing white matter will be designated in the same axial plane to standardize the data. rPH is defined as the maximal change in contrast signal intensity from pre-contrast baseline compared to the lowest signal intensity during contrast bolus, normalized to the signal in the contralateral normal-appearing white matter.

Image processing will occur in a blinded manner using nordicICE software (NordicNeuroLab AS, Bergen, Norway). Signal-intensity curves will be created per voxel. Regions of interest will be designated around the contrast enhancing lesion as seen on T1-post contrast MR. An additional contralateral area of normal-appearing white matter will be designated in the same axial plane to standardize the data. PSR is defined as the percentage of the difference between lowest signal intensity during contrast bolus and the recovery post-contrast signal intensity compared to the peak height.

Image processing will occur in a blinded manner using nordicICE software (NordicNeuroLab AS, Bergen, Norway). Signal-intensity curves will be created per voxel. Regions of interest will be designated around the contrast enhancing lesion as seen on T1-post contrast MR. An additional contralateral area of normal-appearing white matter will be designated in the same axial plane to standardize the data. MTT is defined as the average time in which contrast passes through a given region of brain tissue and is estimated from the contrast concentration-time course curve (CC-TCC) as width of the curve at half maximum height.

National Cancer Institute (NCI)

National Institutes of Health (NIH)

Emory University

Principal Investigator

Blood and Lymph Conditions

Skin and Connective Tissue Diseases

Gland and Hormone Related Diseases

Immune System Diseases

Digestive System Diseases

Rare Diseases

Leukemia

Carcinoma

Breast Neoplasms

Melanoma

Thyroid Neoplasms

Thyroid Diseases

Sarcoma

Lymphoma

Melanoma, Cutaneous Malignant

Colorectal Neoplasms

Skin Neoplasms

Breast Diseases

Skin Diseases

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Endocrine System Diseases

Soft Tissue Sarcoma

Lymphosarcoma

Neuroendocrine Tumor

Neuroepithelioma

Patients receive a personalized SCP and use the INSPIRE mobile application. Patients may receive telehealth stepped care after 1 month.

Patients receive access to a study-specific control website that has annotated links to existing resources for AYA survivors. After 12 months, patients receive a personalized SCP and have access to the digital INSPIRE intervention program without telehealth calls.

Internet Mobile Technology

Access to a study-specific control website

Internet-Based Intervention

Questionnaire Administration

Supportive Care

Informational Intervention

Study Intake

Patricia A. Ganz

Ann H. Partridge

Danielle N. Friedman

Linda Jacobs

K. Scott Baker

This trial studies how well an interactive survivorship program works in improving healthcare resources in adolescent and young adult cancer survivors. By improving access to survivorship resources, health literacy, self-management skills, and support, an interactive survivorship program may help to improve adherence to adolescent and young adult healthcare guidelines and reduce cancer-related distress.

OUTLINE: Patients who have one or more elevated distress or low cardiometabolic or cancer health care adherence are randomized to Arm I or II.

ARM I (INTERVENTION): Patients receive a personalized Survivorship Care Plan (SCP) and use the Interactive Survivorship Program to Improve Healthcare Resources (INSPIRE) mobile application. Patients may receive telehealth stepped care after 1 month.

ARM II (CONTROL): Patients receive access to a study-specific control website that has annotated links to existing resources for adolescent and young adult (AYA) survivors. After 12 months, patients receive a personalized SCP and have access to the digital INSPIRE intervention program without telehealth calls.

Interactive Survivorship Program for the Improvement of Healthcare Resources in Adolescent and Young Adult Cancer Survivors, INSPIRE-AYA Study

INSPIRE-AYA: A Multicenter Interactive Survivorship Program to Improve Healthcare Resources for Adolescent and Young Adult (AYA) Cancer Survivors

Will be assessed by Cancer and Treatment Distress (CTXD). The CTXD is a 22 item Likert type scale that contains 6 subscales: uncertainty, health burden, identity, medical demands, finances, and family strain. Scores on individual items range from 0 (none) to 3 (severe) distress related to an aspect of the cancer experience. Patients will meet the primary endpoint for lack of distress if they score \< 0.9 on the CTXD.

Patients will meet each HCA endpoint if their percent of recommended screenings obtained within the past 12 months is \>= 80% for HCA-CM.

Patients will meet each HCA endpoint if their percent of recommended screenings obtained within the past 12 months is \>= 80% for HCA-SM.

Patients will meet HCA endpoint if their percent of recommended screenings obtained within the past 12 months is \>= 80% for HCA-all.

Fred Hutchinson Cancer Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Utility of Perfusion MRI to Detect Radiation Necrosis in Patients With Brain Metastases	NCT03680144	Invasive Malign... Metastatic Mali...	Dynamic Suscept... Magnetic Resona...	18 Years -	Emory University
Interactive Survivorship Program for the Improvement of Healthcare Resources in Adolescent and Young Adult Cancer Survivors, INSPIRE-AYA Study	NCT04593277	Clinical Stage ... Clinical Stage ... Clinical Stage ... Hematopoietic a... Invasive Malign... Leukemia Lymphoma Malignant Solid... Sarcoma Stage I Colorec... Stage II Colore... Stage III Color... Anatomic Stage ... Anatomic Stage ... Anatomic Stage ... Thyroid Gland C...	Internet Mobile... Internet-Based ... Questionnaire A... Supportive Care Informational I...	18 Years -	Fred Hutchinson Cancer Center
Utility of Perfusion MRI to Detect Radiation Necrosis in Patients With Brain Metastases	NCT03680144	Invasive Malign... Metastatic Mali...	Dynamic Suscept... Magnetic Resona...	18 Years -	Emory University

Spots Global Cancer Trial Database for invasive malignant neoplasm