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NCT Number: NCT00581815

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.

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Key information

Conditions

Adrenal Cortical Cancer Adnexal Diseases Brain Cancer Brain Diseases Brain Neoplasms Breast Cancer Breast Diseases Breast Neoplasms CNS Cancer Carcinoma Carcinoma, Squamous Cell Central Nervous System Diseases Central Nervous System Neoplasms Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms DNA Virus Infections Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Gonadal Disorders HEENT Cancer Head and Neck Neoplasms Hemic and Lymphatic Diseases Herpesviridae Infections Hodgkin Disease Hodgkin's Disease Immune System Diseases Immunoproliferative Disorders Infections Intestinal Diseases Intestinal Neoplasms Kaposi's Sarcoma Kidney Diseases Kidney Neoplasms Liver Cancer Liver Diseases Liver Neoplasms Lung Cancer Lung Diseases Lung Neoplasms Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective and Soft Tissue Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell Neoplasms, Vascular Tissue Nervous System Diseases Nervous System Neoplasms Non-Hodgkin's Lymphoma Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms Prostate Cancer Prostatic Diseases Prostatic Neoplasms Rectal Cancer Rectal Diseases Rectal Neoplasms Renal Cancer Respiratory Tract Diseases Respiratory Tract Neoplasms Sarcoma Sarcoma, Kaposi Skin Diseases Skin and Connective Tissue Diseases Squamous Cell Carcinoma Thoracic Neoplasms Thyroid Cancer Thyroid Diseases Thyroid Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Memorial Sloan-Kettering Cancer Center

New York, 10065, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Proton-decoupled 31P MRS at 1.5T

Device

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

1H Spectroscopy at 1.5T and 3T

Device

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 outcomes

  1. To obtain high resolution spectra from tumors using surface coils to improve sensitivity.

    Time frame: 2 years

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • Columbia University
  • Royal Marsden NHS Foundation Trust
  • St. George's Hospital, London
  • University Medical Center Nijmegen
  • University of Pennsylvania
  • Weill Medical College of Cornell University

Registry information

Important dates

Study start
1997
Primary completion
2014
Study completion
2014
First posted
Dec 28, 2007
Registry last updated
Dec 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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