This phase I trial investigates whether hyperpolarized magnetic resonance imaging (hpMRI) can predict treatment response in patients with thyroid cancer and other head and neck cancer 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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04589624.
Locations matching your search criteria
United States
Texas
Houston
M D Anderson Cancer CenterStatus: Active
Contact: Stephen Yenzen Lai
Phone: 713-792-6528
PRIMARY OBJECTIVE:
I. To obtain pilot metabolic imaging data from hyperpolarized magnetic resonance imaging (hpMRI) methods in patients with head and neck tumors receiving radiation therapy (XRT) and/or systemic therapy (e.g., cisplatin, targeted 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 undergo hpMRI over 30 minutes at baseline, and at 6-8 weeks 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, patients are followed up at 1 day.
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorStephen Yenzen Lai
