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Clinical Trial Record

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Spectroscopy With Surface Coils and Decoupling

1997-02

2014-02

2014-02

582

Study Overview

Spectroscopy With Surface Coils and Decoupling

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.

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.

  • Adrenal Cortical Cancer
  • Brain Cancer
  • Breast Cancer
  • CNS Cancer
  • Colon Cancer
  • HEENT Cancer
  • Hodgkin's Disease
  • Kaposi's Sarcoma
  • Liver Cancer
  • Lung Cancer
  • Non-Hodgkin's Lymphoma
  • Ovarian Cancer
  • Pancreatic Cancer
  • Prostate Cancer
  • Rectal Cancer
  • Renal Cancer
  • Sarcoma
  • Squamous Cell Carcinoma
  • Thyroid Cancer
  • DEVICE: Proton-decoupled 31P MRS at 1.5T
  • DEVICE: 1H Spectroscopy at 1.5T and 3T
  • 97-014

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 Registration Dates Results Reporting Dates Study Record Updates

2007-12-20  

N/A  

2015-12-23  

2007-12-21  

N/A  

2015-12-28  

2007-12-28  

N/A  

2015-12  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Diagnostic

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: 1

DEVICE: Proton-decoupled 31P MRS at 1.5T

  • 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 dev

DEVICE: 1H Spectroscopy at 1.5T and 3T

  • 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.
Primary Outcome MeasuresMeasure DescriptionTime Frame
To obtain high resolution spectra from tumors using surface coils to improve sensitivity.2 years
Secondary Outcome MeasuresMeasure DescriptionTime 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.2 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:
1

    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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

  • Columbia University
  • University of Pennsylvania
  • St. George's Hospital, London
  • Royal Marsden NHS Foundation Trust
  • University Medical Center Nijmegen
  • Weill Medical College of Cornell University
  • PRINCIPAL_INVESTIGATOR: Jason Koutcher, MD, PhD, Memorial Sloan Kettering Cancer Center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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