An Investigational Scan (hpMRI) for Monitoring Treatment Response in Patients With Thyroid Cancer and Other Malignancies of the Head and Neck Undergoing Radiation Therapy and/or Systemic Therapy

May 19, 2026 updated by: M.D. Anderson Cancer Center

Pilot Study of Metabolic Guidance for Therapy in Patients With Thyroid Cancer and Other Malignancies of the Head and Neck

This trial investigates whether hyperpolarized magnetic resonance imaging (hpMRI) can predict treatment response in patients with thyroid cancer and other malignancies of the head and neck undergoing radiation therapy and/or receiving systemic therapy before surgery. An hpMRI is like a standard MRI but involves the use of an imaging contrast agent called hyperpolarized 13-C-pyruvate. Diagnostic procedures, such as hpMRI, may predict a patient's response to treatment and may help plan the best treatment.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

PRIMARY OBJECTIVE:

I. To obtain pilot metabolic imaging data from hyperpolarized magnetic resonance imaging (hpMRI) methods in patients with thyroid tumors or other malignancies of the head and neck receiving radiation therapy (XRT) and/or systemic therapy (e.g., target therapy, checkpoint inhibitors).

SECONDARY OBJECTIVE:

I. To assess early metabolic changes in response to nonsurgical therapy, including standard-of-care fractionated XRT and/or systemic therapy.

OUTLINE: Participants are assigned to 1 of 2 arms.

ARM I: Healthy volunteers undergo MRI over 30 minutes.

ARM II: Patients with thyroid cancer and other malignancies of the head and neck undergo hpMRI over 30 minutes at baseline, and at 1 week after the initiation of treatment. During the scan, patients also receive hyperpolarized 13-C-pyruvate intravenously (IV) over 30 seconds and may receive a standard MRI contrast agent at the discretion of the treating physician.

After completion of study intervention, thyroid cancer and other malignancies of the head and neck patients are followed up at 1 day.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • M D Anderson Cancer Center
        • Contact:
          • Stephen Y. Lai
          • Phone Number: 713-792-6528
        • Principal Investigator:
          • Stephen Y. Lai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Be willing and able to provide informed consent
  • Be informed of the investigational nature of this study
  • Be diagnosed with thyroid cancer and other malignancies of the head and neck with intent for treatment

Exclusion Criteria:

  • Have a history of severe claustrophobia
  • Have electrically, magnetically or mechanically activated implants that would preclude magnetic resonance imaging (MRI)
  • Have a history of cardiac arrhythmia
  • Have an allergy to Gadavist intravenous contrast
  • Estimated glomerular filtration rate (eGFR) < 30
  • If female, be pregnant or breast feeding at time of consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Arm I ( Health Volunteer MRI)
Healthy volunteers undergo MRI over 30 minutes.
Procedure: Magnetic Resonance Imaging
Undergo MRI
Other Names:
  • MRI
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MR Imaging
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging
Procedure: Magnetic Resonance Imaging
Undergo hpMRI
Other Names:
  • MRI
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MR Imaging
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging
Experimental: Arm II (Thyroid Cancer Patient and other malignancies of the head and neck hpMRI)
Patients with thyroid cancer and other malignancies of the head and neck undergo hpMRI over 30 minutes at baseline, and at 1 week after the initiation of treatment. During the scan, patients also receive hyperpolarized 13-C-pyruvate IV over 30 seconds and may receive a standard MRI contrast agent at the discretion of the treating physician.
Procedure: Magnetic Resonance Imaging
Undergo MRI
Other Names:
  • MRI
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MR Imaging
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging
Drug: Hyperpolarized Carbon C 13 Pyruvate
Given IV
Other Names:
  • Hyperpolarized 13C-Pyruvate
  • Hyperpolarized Pyruvate (13C)
Procedure: Magnetic Resonance Imaging
Undergo hpMRI
Other Names:
  • MRI
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MR Imaging
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Metabolic imaging data from hyperpolarized magnetic resonance imaging (hpMRI) methods
Time Frame: 1 year
To measure metabolic imaging data or information derived from hyperpolarized pyruvate MRI (hpMRI) that can be used to identify an early indication of response to therapy in patients with thyroid cancer. Specifically, we measure the kPL-the apparent rate constant for conversion of HP pyruvate into lactate-after one week of treatment compared to baseline measurements acquired prior to start of therapy. The kPL will be calculated from dynamic images of HP pyruvate and its metabolites. The kPL values will be calculated for each tumor and its adjacent tissue by a radiologist and physicist in conjunction using region of interest analysis to identify the margins of the tumor and surrounding normal tissue.
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Early metabolic changes
Time Frame: 1 year
To assess early metabolic changes in response to nonsurgical therapy, including standard-of-care fractionated XRT and/or systemic therapy. The imaging biomarker for tumor metabolism, kPL, will be calculated from dynamic images of HP pyruvate and its metabolites.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
M.D. Anderson Cancer Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Stephen Y Lai, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 12, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 20, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 10, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 19, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2020-0482 (Other Identifier: M D Anderson Cancer Center)
  • NCI-2020-05843 (Registry Identifier: NCI-CTRP Clinical Trials Registry)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Thyroid Gland Carcinoma

  • NCT06959641
    Recruiting
    XL092 for the Treatment of Locally Advanced or Metastatic Radioiodine Refractory Differentiated Thyroid Cancer
    Metastatic Differentiated Thyroid Gland Carcinoma | Refractory Differentiated Thyroid Gland Carcinoma | Stage III Differentiated Thyroid Gland Carcinoma AJCC v8 | Stage IV Differentiated Thyroid Gland Carcinoma AJCC v8 | Metastatic Thyroid Gland Follicular Carcinoma | Metastatic Thyroid Gland Papillary Carcinoma | Refractory Thyroid Gland Papillary Carcinoma | Refractory Thyroid Gland Follicular Carcinoma | Metastatic Thyroid Gland Oncocytic Carcinoma | Locally Advanced Differentiated Thyroid Gland Carcinoma
  • NCT01811212
    Completed
    Cabozantinib-S-Malate in Treating Patients With Refractory Thyroid Cancer
    Recurrent Thyroid Gland Carcinoma | Poorly Differentiated Thyroid Gland Carcinoma | Stage I Thyroid Gland Papillary Carcinoma | Stage II Thyroid Gland Papillary Carcinoma | Stage III Thyroid Gland Papillary Carcinoma | Tall Cell Variant Thyroid Gland Papillary Carcinoma | Stage I Thyroid Gland Follicular Carcinoma | Stage II Thyroid Gland Follicular Carcinoma | Stage III Thyroid Gland Follicular Carcinoma | Stage IVA Thyroid Gland Follicular Carcinoma
  • NCT02973997
    Completed
    Lenvatinib and Pembrolizumab in Differentiated Thyroid Cancers (DTC)
    Poorly Differentiated Thyroid Gland Carcinoma | Recurrent Differentiated Thyroid Gland Carcinoma | Columnar Cell Variant Thyroid Gland Papillary Carcinoma | Follicular Variant Thyroid Gland Papillary Carcinoma | Metastatic Thyroid Gland Follicular Carcinoma | Metastatic Thyroid Gland Papillary Carcinoma | Recurrent Thyroid Gland Follicular Carcinoma | Recurrent Thyroid Gland Papillary Carcinoma | Stage III Differentiated Thyroid Gland Carcinoma AJCC v7 | Stage III Thyroid Gland Follicular Carcinoma AJCC v7
  • NCT04171622
    Active, not recruiting
    Lenvatinib and Pembrolizumab for the Treatment of Stage IVB Locally Advanced and Unresectable or Stage IVC Metastatic Anaplastic Thyroid Cancer
    Poorly Differentiated Thyroid Gland Carcinoma | Thyroid Gland Squamous Cell Carcinoma | Unresectable Thyroid Gland Carcinoma | Metastatic Thyroid Gland Carcinoma | Stage IVB Thyroid Gland Anaplastic Carcinoma AJCC v8 | Stage IVC Thyroid Gland Anaplastic Carcinoma AJCC v8
  • NCT03914300
    Active, not recruiting
    Testing the Combination of Cabozantinib, Nivolumab, and Ipilimumab (CaboNivoIpi) for Advanced Differentiated Thyroid Cancer
    Poorly Differentiated Thyroid Gland Carcinoma | Refractory Differentiated Thyroid Gland Carcinoma | Refractory Thyroid Gland Carcinoma | Follicular Variant Thyroid Gland Papillary Carcinoma | Tall Cell Variant Thyroid Gland Papillary Carcinoma | Differentiated Thyroid Gland Carcinoma | Thyroid Gland Follicular Carcinoma | Thyroid Gland Papillary Carcinoma | Thyroid Gland Oncocytic Carcinoma
  • NCT00381641
    Completed
    Sunitinib Malate in Treating Patients With Thyroid Cancer That Did Not Respond to Iodine I 131 and Cannot Be Removed by Surgery
    Recurrent Thyroid Gland Carcinoma | Refractory Thyroid Gland Carcinoma | Stage III Thyroid Gland Follicular Carcinoma AJCC v7 | Stage IV Thyroid Gland Follicular Carcinoma AJCC v7 | Stage IV Thyroid Gland Papillary Carcinoma AJCC v7 | Stage IVA Thyroid Gland Follicular Carcinoma AJCC v7 | Stage IVA Thyroid Gland Papillary Carcinoma AJCC v7 | Stage IVB Thyroid Gland Follicular Carcinoma AJCC v7 | Stage IVB Thyroid Gland Papillary Carcinoma AJCC v7 | Stage IVC Thyroid Gland Follicular Carcinoma AJCC v7
  • NCT02152995
    Active, not recruiting
    Trametinib in Increasing Tumoral Iodine Incorporation in Patients With Recurrent or Metastatic Thyroid Cancer
    Recurrent Thyroid Gland Carcinoma | Poorly Differentiated Thyroid Gland Carcinoma | Refractory Thyroid Gland Carcinoma | Stage IV Thyroid Gland Follicular Carcinoma AJCC v7 | Stage IV Thyroid Gland Papillary Carcinoma AJCC v7 | Stage IVA Thyroid Gland Follicular Carcinoma AJCC v7 | Stage IVA Thyroid Gland Papillary Carcinoma AJCC v7 | Stage IVB Thyroid Gland Follicular Carcinoma AJCC v7 | Stage IVB Thyroid Gland Papillary Carcinoma AJCC v7 | Stage IVC Thyroid Gland Follicular Carcinoma AJCC v7
  • NCT01208051
    Completed
    Cediranib Maleate With or Without Lenalidomide for the Treatment of Thyroid Cancer
    Refractory Differentiated Thyroid Gland Carcinoma | Unresectable Thyroid Gland Carcinoma | Refractory Thyroid Gland Papillary Carcinoma | Refractory Thyroid Gland Follicular Carcinoma | Refractory Thyroid Gland Hurthle Cell Carcinoma
  • NCT03181100
    Active, not recruiting
    Atezolizumab With Chemotherapy in Treating Patients With Anaplastic or Poorly Differentiated Thyroid Cancer
    Poorly Differentiated Thyroid Gland Carcinoma | Thyroid Gland Anaplastic Carcinoma | Unresectable Thyroid Gland Carcinoma | Metastatic Thyroid Gland Carcinoma | Stage IVB Thyroid Gland Anaplastic Carcinoma AJCC v8 | Stage IVC Thyroid Gland Anaplastic Carcinoma AJCC v8 | Stage IVA Thyroid Gland Anaplastic Carcinoma AJCC v8
  • NCT02393690
    Completed
    Iodine I-131 With or Without Selumetinib in Treating Patients With Recurrent or Metastatic Thyroid Cancer
    Recurrent Thyroid Gland Carcinoma | Poorly Differentiated Thyroid Gland Carcinoma | Stage IV Thyroid Gland Follicular Carcinoma AJCC v7 | Stage IV Thyroid Gland Papillary Carcinoma AJCC v7 | Stage IVA Thyroid Gland Follicular Carcinoma AJCC v7 | Stage IVA Thyroid Gland Papillary Carcinoma AJCC v7 | Stage IVB Thyroid Gland Follicular Carcinoma AJCC v7 | Stage IVB Thyroid Gland Papillary Carcinoma AJCC v7 | Stage IVC Thyroid Gland Follicular Carcinoma AJCC v7 | Stage IVC Thyroid Gland Papillary Carcinoma AJCC v7

Clinical Trials on Magnetic Resonance Imaging

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings