Adrenal Cortical CancerPhase 1NCT00581815
Spectroscopy With Surface Coils and Decoupling
A Phase 1 study testing Proton-decoupled 31P MRS at 1.5T and 1H Spectroscopy at 1.5T and 3T in people with Adrenal Cortical Cancer and Brain Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Adrenal Cortical Cancer, Brain Cancer, Breast Cancer
- What is being tested?
- Proton-decoupled 31P MRS at 1.5T and 1H Spectroscopy at 1.5T and 3T
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 582 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 1997to Feb 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
About this study
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.
Read the 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.
- Conditions
- Adrenal Cortical Cancer, Brain Cancer, Breast Cancer, CNS Cancer, Colon Cancer, HEENT Cancer
- Being tested
- Proton-decoupled 31P MRS at 1.5T, 1H Spectroscopy at 1.5T and 3T
- Medical subject headings
- Brain Neoplasms, Breast Neoplasms, Central Nervous System Neoplasms, Colonic Neoplasms, Hodgkin Disease, Sarcoma, Kaposi, Liver Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proton-decoupled 31P MRS at 1.5TDevice
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 3TDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Device: Proton-decoupled 31P MRS at 1.5T; Device: 1H Spectroscopy at 1.5T and 3T |
What is being measured
The primary outcome is the main question the study is designed to answer.
To obtain high resolution spectra from tumors using surface coils to improve sensitivity.
Measured: 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2007 (estimated)
- Study startFeb 1997
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adrenal Cortical CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 582 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia University, University of Pennsylvania, St. George's Hospital, London, Royal Marsden NHS Foundation Trust, University Medical Center Nijmegen, Weill Medical College of Cornell University
- Responsible party
- Sponsor
- Investigators
- Jason Koutcher, MD, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00581815
- Sponsor's protocol ID
- 97-014
- Status last verified
- Dec 2015
- First submitted
- 20 Dec 2007
- Last updated
- 28 Dec 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spectroscopy With Surface Coils and Decoupling
- ClinicalTrials.gov ID
- NCT00581815
- Acronym / sponsor ID
- 97-014
- Conditions
- Adrenal Cortical Cancer, Brain Cancer, Breast Cancer, CNS Cancer, Colon Cancer, HEENT Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 582 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Columbia University, University of Pennsylvania, St. George's Hospital, London, Royal Marsden NHS Foundation Trust, University Medical Center Nijmegen, Weill Medical College of Cornell University
- Study start
- Feb 1997
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 28 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Proton-decoupled 31P MRS at 1.5T, Device: 1H Spectroscopy at 1.5T and 3T |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proton-decoupled 31P MRS at 1.5TThe 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 | 1 |
| 1H Spectroscopy at 1.5T and 3TThe 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. | Device | 1 |
Primary outcome
To obtain high resolution spectra from tumors using surface coils to improve sensitivity.
Time frame: 2 years
1 secondary outcome
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.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2015.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Koutcher, MD, PhD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Proton-decoupled 31P MRS at 1.5T and 1H Spectroscopy at 1.5T and 3T in people with Adrenal Cortical Cancer and Brain Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To obtain high resolution spectra from tumors using surface coils to improve sensitivity. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2015.