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
Thyroid Gland Carcinoma
What this study involves
The registry says this study is recruiting. Individual locations may have different availability.
- Study type
- Interventional
- Phase
- Phase 1
- Age range
- 18 years - Not specified
- Sex eligible
- All sexes
- Healthy volunteers
- Accepted
- Participants
- 42 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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.
Read the full 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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
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
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Not randomized
- Masking
- No masking
Arm I ( Health Volunteer MRI)
Healthy volunteers undergo MRI over 30 minutes.
Procedure: Magnetic Resonance Imaging
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.
Drug: Hyperpolarized Carbon C 13 Pyruvate · Procedure: Magnetic Resonance Imaging
Hyperpolarized Carbon C 13 Pyruvate DRUG
Given IV
Magnetic Resonance Imaging PROCEDURE
Undergo MRI
Magnetic Resonance Imaging PROCEDURE
Undergo hpMRI
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
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.
Secondary measures
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.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
1 locations
M D Anderson Cancer CenterHouston, Texas, United StatesRecruiting
Study team and timeline
- Lead sponsor
- M.D. Anderson Cancer Center
- Study start
- Aug 12, 2020 Actual
- Primary completion
- May 31, 2027 Estimated
- Study completion
- May 31, 2027 Estimated
- First posted
- Oct 19, 2020 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
Official study title
Pilot Study of Metabolic Guidance for Therapy in Patients With Thyroid Cancer and Other Malignancies of the Head and Neck
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 11, 2026 · Last registry update: Nov 10, 2026