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
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Spectroscopy With Surface Coils and Decoupling

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • To obtain high resolution spectra from tumors using surface coils to improve sensitivity. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 582
Study Start Date: February 1997
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00581815

Locations
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
Investigators
Principal Investigator: Jason Koutcher, MD, PhD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00581815     History of Changes
Other Study ID Numbers: 97-014
Study First Received: December 20, 2007
Last Updated: February 24, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Prostatic Neoplasms
Carcinoma, Squamous Cell
Sarcoma
Pancreatic Neoplasms
Lymphoma, Non-Hodgkin
Breast Neoplasms
Ovarian Neoplasms
Liver Neoplasms
Thyroid Neoplasms
Hodgkin Disease
Brain Neoplasms
Sarcoma, Kaposi
Carcinoma, Renal Cell
Kidney Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Neoplasms, Connective and Soft Tissue
Digestive System Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 18, 2014