Spectroscopy With Surface Coils and Decoupling

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT00581815

Collaborator

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

582

Enrollment

Location

Arm

204

Duration (Months)

2.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
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	Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

582 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Spectroscopy With Surface Coils and Decoupling

Study Start Date :

Feb 1, 1997

Actual Primary Completion Date :

Feb 1, 2014

Actual Study Completion Date :

Feb 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

To obtain high resolution spectra from tumors using surface coils to improve sensitivity. [2 years]

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. [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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