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

NCT04589624 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: 2020-0482NCI-2020-05843
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Thyroid Gland Carcinoma

Outcome Measures

Primary Outcomes (1)

• Metabolic imaging data from hyperpolarized magnetic resonance imaging (hpMRI) methods

  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 Outcomes (1)

• Early metabolic changes

  1 year

Study Arms (2)

Arm I ( Health Volunteer MRI)

ACTIVE COMPARATOR

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)

EXPERIMENTAL

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

Interventions

Hyperpolarized Carbon C 13 Pyruvate DRUG

Given IV

Also known as: Hyperpolarized 13C-Pyruvate, Hyperpolarized Pyruvate (13C)

Arm II (Thyroid Cancer Patient and other malignancies of the head and neck hpMRI)

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

Also known as: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging

Arm I ( Health Volunteer MRI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Thyroid Neoplasms

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Stephen Y Lai

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephen Y Lai

CONTACT

713-792-6528; sylai@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2020
• First Posted: October 19, 2020
• Study Start: August 12, 2020
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: November 21, 2025

Record last verified: 2025-11

Locations

US (1)