An Investigational Scan (hpMRI) for Monitoring Treatment Response in Patients With Thyroid Cancer Undergoing Radiation Therapy and/or Systemic Therapy

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Brief Title

An Investigational Scan (hpMRI) for Monitoring Treatment Response in Patients With Thyroid Cancer Undergoing Radiation Therapy and/or Systemic Therapy

Official Title

Pilot Study of Metabolic Guidance for Therapy in Patients With Thyroid Cancer

Brief Summary

      This trial investigates whether hyperpolarized magnetic resonance imaging (hpMRI) can predict
      treatment response in patients with thyroid 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.
    

Detailed Description

      PRIMARY OBJECTIVE:

      I. To obtain pilot metabolic imaging data from hyperpolarized magnetic resonance imaging
      (hpMRI) methods in patients with thyroid tumors 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 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 patients are followed up at 1 day.
    

Study Phase

Early Phase 1

Study Type

Interventional


Primary Outcome

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

Secondary Outcome

 Early metabolic changes

Condition

Thyroid Gland Carcinoma

Intervention

Hyperpolarized Carbon C 13 Pyruvate

Study Arms / Comparison Groups

 Arm I ( Health Volunteer MRI)
Description:  Healthy volunteers undergo MRI over 30 minutes.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

12

Start Date

August 12, 2020

Completion Date

December 31, 2021

Primary Completion Date

December 31, 2021

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 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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Stephen Y Lai, 713-792-6528, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04589624

Organization ID

2020-0482

Secondary IDs

NCI-2020-05843

Responsible Party

Sponsor

Study Sponsor

M.D. Anderson Cancer Center

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Stephen Y Lai, Principal Investigator, M.D. Anderson Cancer Center


Verification Date

October 2020