Spectroscopy With Surface Coils and Decoupling

Breast Cancer Clinical Trial

Official title:

Spectroscopy With Surface Coils and Decoupling

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00581815
• Other study ID #: 97-014
• Status: Completed
• Phase: Phase 1
• First received: December 20, 2007
• Last updated: December 23, 2015
• Start date: February 1997
• Est. completion date: February 2014

Study information

• Verified date: December 2015
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 582
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Adrenal Cortical Cancer
• Brain Cancer
• Breast Cancer
• Carcinoma, Renal Cell
• Carcinoma, Squamous Cell
• CNS Cancer
• Colon Cancer
• HEENT Cancer
• Hodgkin Disease
• Hodgkin's Disease
• Kaposi's Sarcoma
• Kidney Neoplasms
• Liver Cancer
• Lung Cancer
• Lymphoma, Non-Hodgkin
• Non-Hodgkin's Lymphoma
• Ovarian Cancer
• Pancreatic Cancer
• Pancreatic Neoplasms
• Prostate Cancer
• Rectal Cancer
• Renal Cancer
• Sarcoma
• Sarcoma, Kaposi
• Squamous Cell Carcinoma
• Thyroid Cancer
• Thyroid Neoplasms

Intervention

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
• 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.

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (7)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Columbia University, Royal Marsden NHS Foundation Trust, St. George's Hospital, London, University Medical Center Nijmegen, University of Pennsylvania, Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To obtain high resolution spectra from tumors using surface coils to improve sensitivity.		2 years	No
Secondary	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	No

External Links

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