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Spectroscopy With Surface Coils and Decoupling

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ClinicalTrials.gov Identifier: NCT00581815
Recruitment Status : Completed
First Posted : December 28, 2007
Last Update Posted : December 28, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
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 Phase 1

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 582 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Spectroscopy With Surface Coils and Decoupling
Study Start Date : February 1997
Primary Completion Date : February 2014
Study Completion Date : February 2014

Arms and Interventions

Arm Intervention/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 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.

Outcome Measures

Primary Outcome Measures :
  1. To obtain high resolution spectra from tumors using surface coils to improve sensitivity. [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00581815

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
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
More Information

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00581815     History of Changes
Other Study ID Numbers: 97-014
First Posted: December 28, 2007    Key Record Dates
Last Update Posted: December 28, 2015
Last Verified: December 2015

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Pancreatic Neoplasms
Lymphoma, Non-Hodgkin
Liver Neoplasms
Thyroid Neoplasms
Hodgkin Disease
Sarcoma, Kaposi
Brain Neoplasms
Kidney Neoplasms
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Neoplasms, Connective and Soft Tissue
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Liver Diseases
Head and Neck Neoplasms