- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00581815
Spectroscopy With Surface Coils and Decoupling
December 23, 2015 updated by: Memorial Sloan Kettering Cancer Center
The purpose of this study is to obtain chemical information from part of your body without a biopsy.
This is done using a technique called magnetic resonance spectroscopy (MRS) which is similar to magnetic resonance imaging (MRI) except that signals are detected from the chemicals (spectroscopy) naturally present in your body using radio waves.
To receive this information from your body, small loops of wire (surface coils), placed near the tissue of interest, may be used to more effectively detect signals that come from the chemicals in your body.
The investigators may use a second radio channel simultaneously, which will allow us to obtain greater chemical information (decoupling).
The results may also help us to understand how this study can be used to help other patients with your condition.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The investigators propose to use 1H spectroscopy or 1H decoupled 31P NMR spectroscopy to obtain biochemical information about tumor metabolism in patients, both before and after antineoplastic therapy.
In healthy volunteers, normal tissue metabolism will also be studied.
It is hypothesized that metabolic information may be of prognostic significance, or may be useful for timing of therapy.
Study Type
Interventional
Enrollment (Actual)
582
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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New York, New York, United States, 10065
- Memorial Sloan-Kettering Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients must have suspected or documented neoplastic disease, strongly suspected or established by physical examination, history or conventional histologic biochemical or imaging techniques, or have surgical or aspiration biopsy that will be used to establish a diagnosis
- Patients with obstructive jaundice, both from malignant and non-malignant disease, will be considered for the study
- Patients/volunteers must be clinically stable and not require cardiovascular monitoring
- Patients must be 6 years of age or older and be able to cooperate for an approximately 60 minute examination
- Volunteers must be 18 years of age or older
Exclusion Criteria:
- Inability to cooperate for an MR exam
- Contraindication to MR: Pacemaker, Aneurysmal clips Any ferrous metallic implants which could be deflected by the magnet, Metal implants in field of view, Pregnant women, OR Age and mental status wherein he/she is unable to cooperate for MR study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 1
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The study will use a dual 1H-31P surface coil pair obtained from IGG Medical Advances, Milwaukee, WI.
The coil pair consists of a fixed, 12 cm square 31P resonator co-mounted with a flexible two-loop proton coil.
The P.I. and colleagues have used this device for approximately 10 years with no apparent ill effects
The study will use surface coils manufactured by commercial vendors.
The pulse sequence programs to be used will be monitored automatically by the scanner to insure that SAR limits are not exceeded.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To obtain high resolution spectra from tumors using surface coils to improve sensitivity.
Time Frame: 2 years
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2 years
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
In some of these studies, to enhance our spectral resolution and obtain additional metabolic information, we propose to use decoupling, which will increase both signal quality (the signal to noise ratio) and spectral resolution.
Time Frame: 2 years
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2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Jason Koutcher, MD, PhD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 1997
Primary Completion (Actual)
February 1, 2014
Study Completion (Actual)
February 1, 2014
Study Registration Dates
First Submitted
December 20, 2007
First Submitted That Met QC Criteria
December 21, 2007
First Posted (Estimate)
December 28, 2007
Study Record Updates
Last Update Posted (Estimate)
December 28, 2015
Last Update Submitted That Met QC Criteria
December 23, 2015
Last Verified
December 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Virus Diseases
- Infections
- Immune System Diseases
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- DNA Virus Infections
- Central Nervous System Neoplasms
- Nervous System Neoplasms
- Herpesviridae Infections
- Neoplasms, Vascular Tissue
- Lymphoma
- Sarcoma
- Kidney Neoplasms
- Hodgkin Disease
- Brain Neoplasms
- Sarcoma, Kaposi
Other Study ID Numbers
- 97-014
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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