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
Recruiting
Conditions
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
Interventional
Enrollment (Estimated)
42
Phase
- 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
- Name: Stephen Y Lai
- Phone Number: 713-792-6528
- Email: sylai@mdanderson.org
Study Locations
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
Active Comparator: Arm I ( Health Volunteer MRI)
Healthy volunteers undergo MRI over 30 minutes.
|
Undergo MRI
Other Names:
Undergo hpMRI
Other Names:
|
|
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.
|
Undergo MRI
Other Names:
Given IV
Other Names:
Undergo hpMRI
Other Names:
|
What is the study measuring?
Primary Outcome Measures
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
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
Collaborators
Investigators
- 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)
August 12, 2020
Primary Completion (Estimated)
May 31, 2027
Study Completion (Estimated)
May 31, 2027
Study Registration Dates
First Submitted
September 20, 2020
First Submitted That Met QC Criteria
October 10, 2020
First Posted (Actual)
October 19, 2020
Study Record Updates
Last Update Posted (Actual)
May 22, 2026
Last Update Submitted That Met QC Criteria
May 19, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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
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