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Spectroscopy With Surface Coils and Decoupling

Primary Purpose

Adrenal Cortical Cancer, Brain Cancer, Breast Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Proton-decoupled 31P MRS at 1.5T
1H Spectroscopy at 1.5T and 3T
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Adrenal Cortical Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Memorial Sloan-Kettering Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

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

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.

Full Information

First Posted
December 20, 2007
Last Updated
December 23, 2015
Sponsor
Memorial Sloan Kettering Cancer Center
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
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1. Study Identification

Unique Protocol Identification Number
NCT00581815
Brief Title
Spectroscopy With Surface Coils and Decoupling
Official Title
Spectroscopy With Surface Coils and Decoupling
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
February 1997 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
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

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
582 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Proton-decoupled 31P MRS at 1.5T
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
1H Spectroscopy at 1.5T and 3T
Intervention Description
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 Measure Information:
Title
To obtain high resolution spectra from tumors using surface coils to improve sensitivity.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Koutcher, MD, PhD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mskcc.org
Description
Related Info

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Spectroscopy With Surface Coils and Decoupling

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