Spectroscopy With Surface Coils and Decoupling

Phase 1

Completed

• Conditions: Adrenal Cortical Cancer; Hodgkin's Disease; Ovarian Cancer; Breast Cancer; Kaposi's Sarcoma; Lung Cancer; Renal Cancer; Sarcoma; Colon Cancer; Rectal Cancer
• Interventions: Device: Proton-decoupled 31P MRS at 1.5T; Device: 1H Spectroscopy at 1.5T and 3T

• Registration Number: NCT00581815
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 1997-02
• Study First Submitted: 2007-12-20
• Study First Submitted QC: 2007-12-21
• Study First Posted: 2007-12-28
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-23
• Last Update Posted: 2015-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 582

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	1H Spectroscopy at 1.5T and 3T	-
1	Proton-decoupled 31P MRS at 1.5T	-

Primary Outcome Measures

Name	Time	Method
To obtain high resolution spectra from tumors using surface coils to improve sensitivity.	2 years

Secondary Outcome Measures

Name	Time	Method
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.	2 years

Trial Locations

Locations (1)

Memorial Sloan-Kettering Cancer Center; 🇺🇸 New York, New York, United States