Spectroscopy With Surface Coils and Decoupling

This study has been completed.
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00581815
First received: December 20, 2007
Last updated: February 24, 2014
Last verified: February 2014

December 20, 2007
February 24, 2014
February 1997
February 2014   (final data collection date for primary outcome measure)
To obtain high resolution spectra from tumors using surface coils to improve sensitivity. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00581815 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Spectroscopy With Surface Coils and Decoupling
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.

Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • 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
    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
  • 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.
Experimental: 1
Interventions:
  • Device: Proton-decoupled 31P MRS at 1.5T
  • Device: 1H Spectroscopy at 1.5T and 3T
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
582
February 2014
February 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00581815
97-014
Not Provided
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
  • 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
Memorial Sloan-Kettering Cancer Center
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP