Neoplasms

Nervous System Diseases

All Conditions

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Katherine E Warren, M.D.

Brain tumors represent the most common solid tumor of childhood. Treatment generally entails surgery and radiation, but local recurrence is frequent. Chemotherapy is often used in an adjuvant setting, to delay radiation therapy or for resistant disease. Children with brain tumors are generally followed by imaging studies, such as CT or MRI. Difficulty arises in trying to distinguish tumor regrowth from treatment related edema, necrosis or radiation injury. Proton Nuclear Magnetic Resonance Spectroscopic (NMRS) Imaging is a non-invasive method of detecting and measuring cellular metabolites in vivo. NMRS imaging complements routine MRI by giving chemical information in conjunction with spatial information obtained by MRI.

This study will be conducted to determine NMRS imaging patterns before, during and after chemotherapy in pediatric patients with primary or metastatic brain tumors in an attempt to identify and characterize specific patterns of metabolites related to tumor regrowth, tumor response to therapy, edema or necrosis.

Background:

* Brain tumors represent the most common solid tumor of childhood. Treatment generally includes surgery and radiation, but recurrences are frequent, particularly for high-grade lesions.
* Chemotherapy is often used in an adjuvant setting, to delay radiation therapy or for resistant disease.
* Children with brain tumors are generally followed by imaging studies, such as CT or MRI.
* Difficulty arises in trying to distinguish tumor regrowth from treatment related edema, necrosis or radiation injury.
* Proton Nuclear Magnetic Resonance Spectroscopic (NMRS) Imaging is a non-invasive method of detecting and measuring cellular metabolites in vivo.

Objective:

* To determine NMRS imaging patterns before, during and after chemotherapy in pediatric patients with primary or metastatic brain tumors
* To identify and characterize specific patterns of metabolites related to tumor regrowth, tumor response to therapy, edema or necrosis.

Eligibility:

* Age less than or equal to 21 years.
* Patients entered on this trial will also be entered on one of the Branch s primary brain tumor treatment trials.
* Histologically confirmed primary or metastatic brain tumor. Patients with a brainstem glioma or optic pathway gliomas are not required to have a histologic diagnosis.
* Measurable or evaluable tumor at the time of study entry.

Design:

* This is intended to be a pilot study to define metabolite patterns associated with tumor growth, tumor edema and tumor necrosis as seen on standard MRI; and determine the feasibility of using metabolite patterns to predict response to therapy in pediatric patients with brain tumors.
* Contalateral spectroscopic analysis of normal appearing brain will also be performed when feasible.
* Analysis of results will be stratified according to type of tumor, and prior history of radiation therapy or surgery.

A Pilot Study of 1H-Nuclear Magnetic Resonance Spectroscopic Imaging in Pediatric Patients With Primary and Metastatic Brain Tumors

in vivo measurements of tissue metabolites (NAA, Cho,Cr, Lac) and what they reflect

measurements and differences of signal intensity of peaks obtained for tissue metabolites (NAA, Cho, Cr, Lac)

Contalateral spectroscopic analysis results, stratified according to type of tumor, history of radiation therapy or surgery

National Cancer Institute (NCI)

Infections

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Immune System Diseases

Rare Diseases

Breast Neoplasms

Melanoma

Communicable Diseases

Prostatic Neoplasms

Sarcoma

Lung Neoplasms

Skin Diseases

Acquired Immunodeficiency Syndrome

HIV Infections

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

Skin Neoplasms

Neoplasms, Connective and Soft Tissue

Soft Tissue Sarcoma

Neuroendocrine Tumor

Neuroepithelioma

James L Gulley, M.D.

The purpose of this protocol is to provide patients with adequate informed consent to understand that screening tests with minimal health risk will be performed to evaluate their eligibility for a research study. The protocol makes it clear that patients initial visit to the intramural clinical program may include screening studies that are not medically necessary for disease management, but are done purely for research purposes.

Patients with a known or suspected diagnosis of cancer, HIV infection, skin disorder or immunodeficiency who are being considered for enrollment in a National Cancer Institute intramural clinical research protocol will participate in this consent protocol. It informs patients of screening tests and procedures involving minimal risk that are done for research purposes only, including blood tests, electrocardiogram, standard X-rays (e.g., chest X-ray), bone films, computed tomography (CT), magnetic resonance imaging (MRI), and nuclear medicine studies. It explains that other eligibility screens that are more invasive and involve greater risk, such as a biopsy, will require separate consent.

...

Background:

Patients and healthy volunteers who are being evaluated for NIH Intramural Research Program (IRP) protocols must be screened to determine whether they meet the eligibility criteria prior to enrollment.

Objectives:

Evaluate patient or healthy volunteer eligibility for participation in NIH IRP research protocols.

Collect results of screening test for use on subsequent research protocols as baseline (e.g., pretreatment) values.

Collect specific research samples required for the primary research protocol as part of a screening test or procedure in order to avoid from having to subject the patient to a painful procedure on multiple occasions.

Eligibility:

Patients and healthy volunteers who are being evaluated for and treated on protocols within the NIH IRP.

Design:

This protocol is not a research study of an investigational drug or device.

Screening tests and procedures that are required by the primary research protocols are conducted in order to establish eligibility for these protocols.

In some cases, specific research samples required for the primary research protocol may be collected during the screening process in order to avoid from having to subject the patient to a painful procedure on multiple occasions.

Tissues and biological fluids that are obtained during the screening process will be stored.

Once a patient or healthy volunteer completes the screening process and is either enrolled onto another NIH study or is returned to the care of their local physician they will be taken off study.

Eligibility Screening for the NIH Intramural Research Program Clinical Protocols

.All IPD recorded in the medical record will be shared with intramural investigators upon request.

Tissue remaining from collections during the screening process, either for research eligibility or as clinically indicated may be stored for future research

Collect results of screening test for use on subsequent research protocols as baseline (e.g., pretreatment) values

Collect specific research samples required for the primary research protocol as part of a screening test or procedure in order to avoid from having to subject the patient to a painful procedure on multiple occasions

Gather prospective information on the number of patients screened for a particular study and compare to those enrolled onto an interventional study or natural history study.

Evaluate patient eligibility for participation in NCI/CCR research protocols

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Pilot Study of 1H-Nuclear Magnetic Resonance Spectroscopic Imaging in Pediatric Patients With Primary and Metastatic Brain Tumors	NCT00001574	Brain Neoplasm Brain Cancer Brain Tumor, Pr...		- 21 Years	National Institutes of Health Clinical Center (CC)
Eligibility Screening for the NIH Intramural Research Program Clinical Protocols	NCT00026754	Breast Cancer Prostate Cancer Lung Cancer Sarcoma Melanoma		1 Month -	National Institutes of Health Clinical Center (CC)

Spots Global Cancer Trial Database for scans

Every month we try and update this database with for scans cancer trials from around the world to help patients and their families find trials that might be right for them.
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Spots Global Cancer Trial Database for scans

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