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Spectroscopy With Surface Coils and Decoupling

NCT ID: NCT00581815

Last Updated: 2015-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

582 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-02-28

Study Completion Date

2014-02-28

Brief Summary

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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

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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.

Conditions

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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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Proton-decoupled 31P MRS at 1.5T

Intervention Type 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

Intervention Type 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.

Interventions

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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

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Columbia University

OTHER

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role collaborator

St. George's Hospital, London

OTHER

Sponsor Role collaborator

Royal Marsden NHS Foundation Trust

OTHER

Sponsor Role collaborator

University Medical Center Nijmegen

OTHER

Sponsor Role collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jason Koutcher, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Site Status

Countries

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United States

Related Links

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http://www.mskcc.org

Related Info

Other Identifiers

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97-014

Identifier Type: -

Identifier Source: org_study_id