Clinical trial NCT00581815: Spectroscopy With Surface Coils and Decoupling
Official title: Spectroscopy With Surface Coils and Decoupling
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: 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
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Columbia University
name: University of Pennsylvania
name: St. George's Hospital, London
name: Royal Marsden NHS Foundation Trust
name: University Medical Center Nijmegen
name: Weill Medical College of Cornell University
First posted: 2007-12-28
Enrollment: 582
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: To obtain high resolution spectra from tumors using surface coils to improve sensitivity.
timeFrame: 2 years
Secondary outcomes:
measure: 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.
timeFrame: 2 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Jason Koutcher, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: