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

Official title

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

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.

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.

Interventions

• Drug Hyperpolarized Carbon C 13 Pyruvate
  Given IV
• Procedure Magnetic Resonance Imaging
  Undergo MRI
• Procedure Magnetic Resonance Imaging
  Undergo hpMRI

Primary outcome measures

• Metabolic imaging data from hyperpolarized magnetic resonance imaging (hpMRI) methods [Time frame: 1 year]

Secondary outcome measures (1)

• Early metabolic changes [Time frame: 1 year]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Diagnostic

Study locations

United States · 1 center

• M D Anderson Cancer Center — Houston

Identifiers

NCT: NCT04589624 · 2020-0482 · NCI-2020-05843 · 2020-0482

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗