Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04589624

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location status: Recruiting

Location contact

Stephen Y. Lai

CONTACT

713-792-6528

Stephen Y. Lai

PRINCIPAL_INVESTIGATOR

About this study

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 can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 and study plan

Hyperpolarized Carbon C 13 Pyruvate

Drug

Given IV

Other names: Hyperpolarized 13C-Pyruvate, Hyperpolarized Pyruvate (13C)

Magnetic Resonance Imaging

Procedure

Undergo MRI

Other names: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging

Primary outcomes

  1. 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 outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Stephen Y Lai

CONTACT

[email protected]

713-792-6528

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Oct 19, 2020
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.