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

Phase 1RecruitingNCT04589624

M.D. Anderson Cancer Center42 enrolled

Overview

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.

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

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 1 year

Secondary Outcomes

Early metabolic changes

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.