Spectroscopy With Surface Coils and Decoupling
1 other identifier
interventional
582
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Feb 1997
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 1997
CompletedFirst Submitted
Initial submission to the registry
December 20, 2007
CompletedFirst Posted
Study publicly available on registry
December 28, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedDecember 28, 2015
December 1, 2015
17 years
December 20, 2007
December 23, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
To obtain high resolution spectra from tumors using surface coils to improve sensitivity.
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.
2 years
Study Arms (1)
1
EXPERIMENTALInterventions
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
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Memorial Sloan Kettering Cancer Centerlead
- Columbia Universitycollaborator
- University of Pennsylvaniacollaborator
- St. George's Hospital, Londoncollaborator
- Royal Marsden NHS Foundation Trustcollaborator
- University Medical Center Nijmegencollaborator
- Weill Medical College of Cornell Universitycollaborator
Study Sites (1)
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jason Koutcher, MD, PhD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 20, 2007
First Posted
December 28, 2007
Study Start
February 1, 1997
Primary Completion
February 1, 2014
Study Completion
February 1, 2014
Last Updated
December 28, 2015
Record last verified: 2015-12