Papillary Thyroid CancerNCT02178345
Predictive MRI Metrics for Tumor Aggressiveness in Papillary Thyroid Cancer
An observational study of Papillary Thyroid Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
Magnetic resonance imaging (MRI) is a diagnostic technique that takes pictures of organs of the body. It uses magnetic fields and radio waves that cannot be felt. Perfusion MRI uses faster imaging. It also includes a contrast material that is given by vein. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Papillary Thyroid Cancer
- What is being tested?
- diffusion weighted (DW) MRI and dynamic contrast agent (DCE) MRI
- Type of treatment
- Surgery or procedure
- How many people
- 123 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jun 2014to 3 Dec 2021
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Surgical Head and Neck Cancer clinic MSKCC
Who may be able to join
- Biopsy proven Papillary Thyroid Cancer (regardless of genotype and including all subtypes such as follicular or mixed papillary follicular) or suspicious for Thyroid Cancer
- Thyroidectomy or lobectomy planned as definitive treatment for Thyroid Cancer or patients on active surveillance management approach
- Age ≥18 years
Who cannot join
- Patient would require anesthesia for the study
- Patients who are claustrophobic Patients with tumor size greater than 5 cm in diameter as measured at imaging (ultrasonography or MRI) before treatment
- Patients who have presence of a known contraindication to MRI
- Pacemaker
- Aneurysmal clips
- Metal implants in field of view
Show all 11Show fewer
- Pregnant
- Age and mental status wherein he/she is unable to cooperate for MRI study Patients who have presence of a known contraindication to DCE-MRI may not participate in that portion of the study
- Known reaction to Gd-DTPA, contrast agent
- Chronic kidney disease
- nursing women
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
Magnetic resonance imaging (MRI) is a diagnostic technique that takes pictures of organs of the body. It uses magnetic fields and radio waves that cannot be felt. Perfusion MRI uses faster imaging. It also includes a contrast material that is given by vein. This makes specific organs, blood vessels, or tumors easier to see. Diffusion MRI lets us measure the motion of water in the tumor.
Perfusion and diffusion MRI give extra information which is not available with the regular MRI. A regular MRI only shows pictures of the tumor. Thyroid MRI scans are not part of the current standard of care. The purpose of this study is to see if new MRI methods can give us more information about the tumor.
Read the detailed description
The aim of this pilot study clinical trial is to provide MRI biomarkers as quantitative (surrogate) biomarkers of aggressiveness in papillary thyroid cancer (PTC) including PMCs and to lay out the scientific basis for their translation into patient management. In this study we will perform specially designed diffusion weighted MRI (DW-MRI) and dynamic contrast agent MRI (DCE-MRI) protocols in the PTC patients.
DW-MRI allows for quantifying water diffusion which has been shown to be related to tumor cellularity (29). Particularly, appropriate modeling with DW-MRI data acquired at multiple b values will enable quantifying tumor cellularity and vascularity simultaneously (30-32). DCE-MRI with proper compartmental modeling will yield metrics related to tumor-vessel permeability, tumor perfusion, and extracellular-extravascular volume fraction (33, 34). These facts provide the potential of DW-MRI and DCE-MRI metrics as quantitative imaging biomarkers of tumor aggressiveness in PTCs. The DW-MRI and DCE-MRI may ultimately help in personalized management approach, in which imaging biomarkers may be used to recommend either immediate surgery or active surveillance for PTC patients.
- Conditions
- Papillary Thyroid Cancer
- Being tested
- diffusion weighted (DW) MRI, dynamic contrast agent (DCE) MRI
- Keywords
- MRI, 14-126
- Medical subject headings
- Thyroid Cancer, Papillary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diffusion weighted (DW) MRIProcedure or surgery
dynamic contrast agent (DCE) MRIProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Surgical patients | The patients will undergo DW-MRI and (if patient is eligible and agrees) DCE-MRI study prior to surgery. The maximum time interval allowed between the MRI study and surgery will be six months. Receives: Procedure: diffusion weighted (DW) MRI; Procedure: dynamic contrast agent (DCE) MRI | |
| surveillance management patients | The patients will undergo DW-MRI and (if patient is eligible and agrees) DCE-MRI study while being on active surveillance.These patients can also receive the same DW and DCE MRI as a followup a year after the first. Receives: Procedure: diffusion weighted (DW) MRI; Procedure: dynamic contrast agent (DCE) MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
feasibility of MRI biomarkers
The long-term goal of this work will be to perform clinical trials of personalized management approach, in which imaging biomarkers are used to recommend either immediate surgery or active surveillance for PTC patients.
Measured: up to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2014 (estimated)
- Study start24 Jun 2014
- Primary completion3 Dec 2021
- Study completion3 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Papillary Thyroid 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amita Dave, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02178345
- Sponsor's protocol ID
- 14-126
- Status last verified
- Dec 2021
- First submitted
- 25 Jun 2014
- Last updated
- 8 Dec 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive MRI Metrics for Tumor Aggressiveness in Papillary Thyroid Cancer
- ClinicalTrials.gov ID
- NCT02178345
- Acronym / sponsor ID
- 14-126
- Conditions
- Papillary Thyroid Cancer
- Keywords
- MRI, 14-126
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 24 Jun 2014 (actual)
- Primary completion
- 3 Dec 2021 (actual)
- Study completion
- 3 Dec 2021 (actual)
- First posted
- 30 Jun 2014 (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.
Magnetic resonance imaging (MRI) is a diagnostic technique that takes pictures of organs of the body. It uses magnetic fields and radio waves that cannot be felt. Perfusion MRI uses faster imaging. It also includes a contrast material that is given by vein. This makes specific organs, blood vessels, or tumors easier to see. Diffusion MRI lets us measure the motion of water in the tumor.
Perfusion and diffusion MRI give extra information which is not available with the regular MRI. A regular MRI only shows pictures of the tumor. Thyroid MRI scans are not part of the current standard of care. The purpose of this study is to see if new MRI methods can give us more information about the tumor.
Detailed description
The aim of this pilot study clinical trial is to provide MRI biomarkers as quantitative (surrogate) biomarkers of aggressiveness in papillary thyroid cancer (PTC) including PMCs and to lay out the scientific basis for their translation into patient management. In this study we will perform specially designed diffusion weighted MRI (DW-MRI) and dynamic contrast agent MRI (DCE-MRI) protocols in the PTC patients.
DW-MRI allows for quantifying water diffusion which has been shown to be related to tumor cellularity (29). Particularly, appropriate modeling with DW-MRI data acquired at multiple b values will enable quantifying tumor cellularity and vascularity simultaneously (30-32). DCE-MRI with proper compartmental modeling will yield metrics related to tumor-vessel permeability, tumor perfusion, and extracellular-extravascular volume fraction (33, 34). These facts provide the potential of DW-MRI and DCE-MRI metrics as quantitative imaging biomarkers of tumor aggressiveness in PTCs. The DW-MRI and DCE-MRI may ultimately help in personalized management approach, in which imaging biomarkers may be used to recommend either immediate surgery or active surveillance for PTC patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical patients | – | Procedure: diffusion weighted (DW) MRI, Procedure: dynamic contrast agent (DCE) MRIThe patients will undergo DW-MRI and (if patient is eligible and agrees) DCE-MRI study prior to surgery. The maximum time interval allowed between the MRI study and surgery will be six months. |
| surveillance management patients | – | Procedure: diffusion weighted (DW) MRI, Procedure: dynamic contrast agent (DCE) MRIThe patients will undergo DW-MRI and (if patient is eligible and agrees) DCE-MRI study while being on active surveillance.These patients can also receive the same DW and DCE MRI as a followup a year after the first. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Surgical Head and Neck Cancer clinic MSKCC
Key inclusion criteria (3 listed)
- Biopsy proven Papillary Thyroid Cancer (regardless of genotype and including all subtypes such as follicular or mixed papillary follicular) or suspicious for Thyroid Cancer
- Thyroidectomy or lobectomy planned as definitive treatment for Thyroid Cancer or patients on active surveillance management approach
- Age ≥18 years
Key exclusion criteria (11 listed)
- Patient would require anesthesia for the study
- Patients who are claustrophobic Patients with tumor size greater than 5 cm in diameter as measured at imaging (ultrasonography or MRI) before treatment
- Patients who have presence of a known contraindication to MRI
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 |
|---|---|---|
| diffusion weighted (DW) MRI | Procedure or surgery | Surgical patients, surveillance management patients |
| dynamic contrast agent (DCE) MRI | Procedure or surgery | Surgical patients, surveillance management patients |
Primary outcome
feasibility of MRI biomarkers
Time frame: up to six months
The long-term goal of this work will be to perform clinical trials of personalized management approach, in which imaging biomarkers are used to recommend either immediate surgery or active surveillance for PTC patients.
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 8 Dec 2021.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
Related trials for Papillary Thyroid Cancer
Recruiting
Active Surveillance of Papillary Thyroid Microcarcinoma
Papillary Thyroid Microcarcinoma
RecruitingObservational study
Definition of Mutational Profile of Papillary Thyroid Tumors by Mass-ARRAY
Papillary Thyroid Cancer
Not yet recruitingObservational study
Serum Treg/Th17-Related Cytokines and Systemic Inflammatory Indices in Differentiated Thyroid Cancer
Differentiated Thyroid Cancer (DTC), Papillary Thyroid Carcinoma
RecruitingObservational study
Studies on Tumors of the Thyroid
Hurthle Cell Thyroid Cancer, Tall Cell Variant Thyroid Cancer
Active, not recruitingPhase 3
A Study of Cabozantinib Compared With Placebo in Subjects With Radioiodine-refractory Differentiated Thyroid Cancer Who Have Progressed After Prior Vascular Endothelial Growth Factor Receptor (VEGFR) -Targeted Therapy
Differentiated Thyroid Cancer
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.
Amita Dave, 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?
An observational study of Papillary Thyroid 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 3 inclusion and 11 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 8 Dec 2021. 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.
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?
feasibility of MRI biomarkers (time frame: up to six months). 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 8 Dec 2021.